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17735, "resolved▁to": 17736, "pharmacy▁": 17737, "▁applicable▁sit": 17738, ".\n\n2.3": 17739, "procedures▁and▁": 17740, "procedures▁are▁": 17741, "optional▁": 17742, "secondary": 17743, "Evaluations": 17744, "272−636.4.0": 17745, "held▁for": 17746, "▁To▁be▁": 17747, "▁any▁other▁reason": 17748, "▁reduced▁": 17749, "▁alone▁or": 17750, "ate,▁BUN": 17751, "▁discontinuation▁from▁study▁treatment": 17752, "▁terminate▁the▁": 17753, "ed▁according▁to▁treatment": 17754, "\n\nWBC": 17755, "schedule▁of": 17756, "▁Perform": 17757, ",▁O'": 17758, "EPLAC": 17759, "rectum": 17760, "work▁activities.▁Up▁and▁about": 17761, "assignment": 17762, "see▁Table▁": 17763, "▁pemetrexed▁plus▁cisplatin": 17764, "objective▁progression": 17765, "judged▁to▁be▁": 17766, "▁March▁2006": 17767, ".▁Exclusion▁Criteria": 17768, "▁Followed▁by▁M": 17769, "delayed▁until": 17770, "▁contact▁with": 17771, "used▁throughout▁the▁study": 17772, "▁Access": 17773, "▁you▁are▁pregnant": 17774, "▁use▁an": 17775, 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"al▁sourc": 17816, ".\n\nIt": 17817, "▁d▁o": 17818, "▁Procedures▁": 17819, "lower▁than": 17820, "ed▁March": 17821, "▁organ▁clas": 17822, "▁confidentiality": 17823, "e▁include▁": 17824, "ella▁F": 17825, ".▁Pharmacokinetic": 17826, "hemistry▁panel:▁sodium,▁potassium,▁chloride,▁bicarbon": 17827, "▁positive▁benefit": 17828, "▁one▁of▁the▁following": 17829, "OPG": 17830, ".\n\n.▁E▁S▁U\n\nE▁R▁O▁F▁E▁B\n\nY▁T▁I▁D▁I▁L▁A▁V": 17831, "▁0.85": 17832, "ince▁this▁": 17833, "withdrawn▁from▁the▁study▁": 17834, "superior▁to": 17835, "▁stable▁diseas": 17836, "▁tumor▁cells▁and▁the▁proposed▁mechanism▁of▁action": 17837, "2007;": 17838, "number▁of▁event": 17839, "uoropyrimidine▁": 17840, "ematology▁panel:": 17841, "▁log-rank▁test": 17842, "yroid": 17843, "▁Cox▁model": 17844, "▁Cox▁regression▁model": 17845, "▁locally▁advanced▁": 17846, "probabl": 17847, "duration▁of▁response▁(": 17848, "▁Definitions": 17849, "▁AND▁REPLAC": 17850, "▁SAMPLE": 17851, ",▁we▁will▁have▁": 17852, "▁take▁part▁in": 17853, 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21179, "▁the▁interim▁analysis▁": 21180, "database▁": 21181, "fully": 21182, "enocarcin": 21183, "improves▁": 21184, "improved▁to": 21185, "..........................": 21186, "▁Registration": 21187, "▁calcium▁and▁vitamin▁D": 21188, "immunotherapy": 21189, "immunogenicity": 21190, ".▁Treatment▁Compliance▁": 21191, "\n\nx▁x▁x▁x▁x▁x▁x": 21192, "bone▁marrow": 21193, "▁evaluate▁the▁response▁to": 21194, "secondary▁efficacy▁endpoint": 21195, "▁as▁well▁as▁the▁": 21196, "▁small▁molecul": 21197, "▁site▁personnel": 21198, "▁decides▁": 21199, "\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040138▁Date:▁19▁February▁2008": 21200, "▁Overall▁Survival": 21201, "▁the▁present": 21202, "e▁discover": 21203, "▁of▁six": 21204, "▁coum": 21205, "followed▁every▁": 21206, "Drug▁Administration": 21207, ".▁Kris": 21208, ".\n\nWhat▁are▁the▁": 21209, "▁had▁any▁": 21210, "▁Evaluate▁": 21211, "▁date▁of▁death": 21212, "unless▁otherwise▁": 21213, "▁frequency▁": 21214, "ed▁for▁each▁treatment▁group": 21215, "employed▁to": 21216, 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"▁ever▁comes▁first.▁If▁the▁benefit:risk▁profile▁is▁not▁positiv": 29692, "ensive▁treatment▁in▁an▁emergency▁room▁or▁at▁home▁for": 29693, "▁party▁or▁move▁them▁to▁another▁location,▁": 29694, "read▁the▁attached▁protocol▁entitl": 29695, "6▁planned▁cycl": 29696, "HuEPO": 29697, "kilograms)": 29698, "al▁Anti-Inflammatory▁Drug": 29699, "uration▁for▁Participant": 29700, "▁COLLECTION": 29701, "acquisition▁of▁informed▁consent": 29702, "▁or▁ECHO": 29703, "uties.▁All▁persons▁authorized▁to": 29704, "ize▁discoveries▁or▁in": 29705, "▁nor▁other▁participants▁in▁this▁research▁will▁compensate▁you▁if▁this▁happens": 29706, "▁and▁as▁needed▁thereafter": 29707, "▁TISSUE": 29708, "▁RISKS▁AND▁DISCOMFOR": 29709, "event-free▁rates▁at": 29710, "clude▁the▁selection▁of": 29711, "ing▁the▁article▁or▁revis": 29712, "▁at▁start▁of▁cycle,▁hold▁and▁check": 29713, "▁study▁initiation▁and▁as▁needed▁thereafter": 29714, "s▁and▁p-values": 29715, "s▁and▁investigative▁staff": 29716, "ly▁as▁possible▁up▁to": 29717, 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"ppend ix", "\n\n 2", "im en", "e ath", "▁ form", "y▁ of", "arg et", "re x", "b as", "▁s hould▁be▁", "at ive▁", "ro ll", "ar k", "__ __", "ear ch", "ar d▁", "ace bo", "▁ other", ".... ..", "ar i", "n e", "▁l esion", "▁the▁in vestigator", "\n\n R", "ul ar", "emet rex", "1 7", "s ubject", "▁y our", "▁T ▁I", "S tudy▁", "ax el", "t en", "it or", "eter min", "in d", "in ib", "et ic", "N C", "▁ -", "emother apy▁", "MC -", "▁to ▁be▁", "▁A d", "t o", "▁th e\n\n", "▁p re", "ed ▁as▁", "2 4", "ev ac", "ity▁ of", "▁h as▁", "iz umab", "urviv al", "evac izumab", "▁S tudy▁", "▁al so", "▁y ou", "th e▁", "as s", "enc e▁", "d es", "u al", "eas ure", "f f", "▁a ▁s", "▁the▁ study", "\n\n F", "▁c ycl", "pres ent", "oun t", "1 4", "\n\n T", "e ,", "ri al▁", "▁E ▁L", "................................................................ ................................", "\n\n 3", "00 0", "▁ im", "5 4", "c i", "asel ine▁", "cons ent", "enc e▁of", "pro tocol", "ser v", "act or", "O n", "s h", "at ing", "d ur", "r on", "es e▁", "▁the▁p atient", "ch ed", "ed ,▁", "ched ul", "xim ately▁", "d ra", "res pons", "E R", "\n\n Y", "▁ad dition", "en ing", "▁ The▁", "ow n", "▁f ollow", "ific ation", ".▁ D", "▁the▁ l", "\n\nS ▁I", "S T", "n o", "s ▁are▁", "▁d ose▁", "▁in ter", "d▁ of", "▁le ast", "oc i", "▁re g", "y ,▁", "com plet", "▁ W", "c oll", "ed ▁as", "etast atic", "RA S", "K RAS", "▁th an", "rim ary▁", "p r", ".\n\n A", "e )", "▁o b", "eff icac", "\n\n The▁", "▁to xic", "ed▁in ▁the▁", "\n\n 4", ".▁ F", "▁d ay", "l e", "▁c ons", "on fidential", "ic ally▁", "i d▁", "u c", "d ata", "I -", "ab il", ".\n\n P", "e▁ b", "5 -", "requ ire", "s ▁to", "un it", "▁ther apy", "s ▁that", "al▁pro duct", "1 3", "2 3", "\n\n I", "r ent", "in al", "p ri", "▁ar m", "▁mg/ m", "dra w", ",▁ S", "i -", "▁p anitumumab", "▁200 7", "h y", "▁c lin", "▁v isit", "d efin", "is k", "y st", "ol or", "lin d", "L C", "iv en", "pprov ed", "ark er", "unit inib", "o th", "▁patients▁ with", "qu est", "s▁ or", "8 0", "ym pt", "s on", "▁ it", "ympt om", "vestigation al▁product", "bin ation", "c ar", "ra ph", "p are", "st it", "\n\nA d", "act ion", "▁ther apy▁", "a ys", "▁ac cord", "es ,▁", "arm ac", "evel op", "/ or", "▁c ar", "▁w as▁", "res ult", "▁C linical▁", "f l", "is platin", "▁a ct", "per formed▁", "ad minist", "▁V ersion", "wh ich", "C linical▁", "ug h", "in ▁the▁", "ing ▁to", "▁m in", "emother apy", "un g", "e qu", "r m", "▁d eath", "em ber", ".\n\n S", "at ed▁to", ") ▁", "cre as", "al th", "l evel", "m ain", "includ ing", "e▁t reatment", "E vent", "5 %", "u res", "m ust▁be▁", "▁ Th", "con d", "up pl", "bo platin", "19 9", "▁3 0", "u id", "et w", "ran s", "d os", "all y", "p atients▁", "d▁e▁v▁o▁r▁p▁p▁A \n\nProduct:", "A n", "S C", "▁pro gression", "▁ evalu", "e▁ and▁", "pro vid", "p rior▁to", "ro p", "s ign", "us ing", "urviv al▁", "ro ugh", "pons or", "ed ▁and▁", "ac k", "olor ect", "▁d i", "▁A n", "yst em", "2 01", "▁the▁ study▁", "▁in clud", "r al▁", "may▁ be▁", "▁p eri", "ific ant", "▁m ust▁be▁", "00 7", "s :", "▁o ver", "etw een", "et u", "if fer", "▁s ampl", "▁f actor", "xim ab", "pec ific", "etu ximab", "at e▁of", "▁A mendment", "r u", "▁in fusion", "E -", "t ion", "o x", "ent er", "ce ive▁", "ro w", "olog y▁", "▁1 3", "at iv", "per form", "fir m", "is su", ".▁ R", "S A", "N D", "it amin", "ol v", "end point", "efor e▁", "el y", ", ▁a", "y ou", "un til", "re ceiv", "formed▁ consent", "▁16 2", "MG ▁162", "▁mg/m 2", "an n", ".▁ 200", "ed▁ from", "▁s it", "en roll", "▁c ell", "cons ider", "quest ion", "\n\n 0", "ep end", "▁subject s▁", "p on", "▁y ear", "id e▁", "ay▁ 1", "▁the▁s ubject", "In vestigator", "verse▁ Event", "▁dos e▁of", "in ter", "▁com plet", "J M", "\n\n H", "ag n", "▁g roup", "▁this▁ study", "N A", "d iscontinu", "▁a p", "it al", "▁C om", "▁appro ximately▁", "ag ing", "▁of▁1 2", "▁p articip", "▁A B", "ap pro", "ed .\n\n", "▁d iscontinu", "h em", ",▁ P", "E S", "r andomiz", "▁t reat", "asel in", "S t", "v alu", "\n\n \n\n", "d ocument", "st at", "▁s ub", "out com", "in c", "c ancer", "c rib", "C l", "k n", "y ▁and▁", "Z D", "▁C T", "▁the ir", "▁ et▁al", "O R", "▁in d", "re as", "du c", "pl ic", "▁t ak", "ith er", "il d", "▁ if", "e▁th at", "3 6", "d isease▁", "▁m od", "es▁ will▁be▁", "h ase▁", "ed \n\n", ".▁ B", ", \n\n", "es s▁", "is h", "res ponse▁", "ot ent", "e b", "r int", "▁d o", "EN TI", "en os", "▁analys is", "n umber", "olorect al", "▁and /or", "▁cont inu", "▁P anitumumab", "enos umab", "- 0", ". 8", "\\ A", "w o", "es▁ in", "ed▁ s", "▁re ceive▁", "coll ect", "\n\n x", "▁ =", "i om", "ro l", "v al", "▁ occur", "ff icac", "\n\n 6", "I- 007", "▁d ays", "s sessment", "▁s can", "▁re port", "d is", "er um", ".▁ M", "▁pro vid", "▁res ponse▁", "I T", "d ose▁", "▁C ancer", "▁the▁t im", ") ▁and▁", "aborator y▁", "▁ event", "▁P age▁", "c ess", "................................ ................", "▁disease▁ progression", "1 6", "▁s hould▁", "v anc", "e▁ S", ",▁ s", "se qu", "easure ment", "l oc", "▁th ese▁", "ro s", "iz ation", "m od", "ati st", "- t", "s▁ b", ",▁ M", "eri ous", "\n\n 7", "res s", "al i", "ed :", "3 3", "row th", "G E", "mend ed▁", "oci ated▁", "▁d is", "▁re qu", ",▁ 200", "▁s h", "el ect", "▁may▁ be▁", "sequ ent", "e alth", "h a", "an y▁", "um m", "12 0", "R O", ".▁ H", "ab el", "ar r", "▁m or", "▁com bination", ".2 .1", "- rel", "▁clin ical", "m all", "▁d rug", "▁ up", "s▁ will", "it ant", "ced ure", "w eek", "c in", "▁d ur", "el in", "com itant", "▁n on-", "▁study ▁treatment", "un ction", "▁th rough", "▁s urvival", "eas ur", "X -", "▁m ust", "ib od", "cur rent", ",▁ C", "▁h our", "▁l oc", "3 E-", "med ication", "ob serv", "▁re l", "1 -", "▁( A", "reg n", "administ er", "s ub", "▁l evel", "e▁of ▁the▁", "1 )", "T rial▁", "▁m etastatic", ". 9", "▁R es", "▁b lood▁", "cre ening", "TI ON", "ali platin", "▁res ult", "n on-", "ef it", "▁H ▁T", "emetrex ed▁", "ed▁on ▁the▁", "rade▁ 3", "s ampl", "ation ▁of▁", "y t", "ur g", "m an", "e cond", ".▁A n", "arget ▁lesion", "n orm", "oc et", "revi ew", "\n\n In", ",▁ b", "es▁ for", "ow er", "▁st at", "ocet axel", "s ,", "▁1 9", "I N", "I ST", "c ul", "e .", ".▁ N", "c ol", "ex t", "duct ion", "W h", "ul ator", "▁and ▁the▁", "ron ic", "▁act iv", "ib il", "▁g en", "................................................................................ ........", "R B", "v ail", "A d", "r isk", "it ab", "e▁ m", "\n\n B", "eth od", "m er", "th or", "om a", "▁follow -up", "▁b y▁", "ac il", "te in", "▁ –", "es▁ (", "ject iv", "▁O n", "▁ch emotherapy▁", "d ▁to", "\n\n M", "▁c an", "abl e▁to", "▁administ er", "A B", "con duct", "▁wh ich", "▁in formation", "CR F", "r ic", "s et", "▁res pons", "s ▁after", "og raph", "en efit", "olog ic", "▁n umber", "▁r andomization", ".▁Th is▁", "ced ures", "ow ever", "itamin ▁D", "▁re ceiv", "n d", "▁ [", "en d▁of", "▁to ▁", "mit t", "g iven", "u or", "0 %", "p art", "clin ical", "etast as", "pri ate▁", "u ll", "Trial▁ Protocol", "▁b aseline▁", "▁S ▁A", "clin ical▁", "epend ent", "u thor", "re ast", "ENTI AL", "h ib", "r ati", "▁pl acebo", "e▁ or", "ur ther", "ot ec", "▁un til", "▁E▁L ▁P", "▁S▁A ▁E▁L▁P", "b l", "p ression", "og en", "eth er", "uid elin", "otec an", "▁t issu", "iv id", "ch ang", "▁administ ration", "iom arker", "▁an y", "I V", "▁C ▁O", "▁N ▁E", "op ulation", "r y▁", "in otecan", "▁th is", "pl ac", "O X", "R E", "▁M ▁U", "wh en", "rim ary", ".▁T ▁N▁E", "▁C▁O ▁D", "▁M▁U ▁C▁O▁D", ".▁T▁N▁E ▁M▁U▁C▁O▁D", "▁N ▁I", "▁F ▁E", "olorectal ▁cancer", "▁R ▁O", "y our", "▁E ▁T", "O S", "▁P FS", "▁S ection", "▁I D", "▁R ▁P", "ce ll", "▁F▁E ▁B", "▁R▁O ▁F▁E▁B", "C AE", "w ere▁", "II I", "▁N▁I ▁R▁P", "▁E▁T ▁N▁I▁R▁P", "▁S ▁U", "▁ther e▁", "it ies", "F U", "▁d ocument", "▁P ▁O", ".▁E ▁S▁U", ".\n\n The▁", "▁L ▁A", "▁P▁O ▁C", "W ith", "▁I ▁L▁A", "▁D ▁I▁L▁A", "▁T▁I ▁D▁I▁L▁A", "▁T▁I▁D▁I▁L▁A ▁V", "- s", "im it", "il e▁", "▁ad vanc", "in al▁", ",▁ A", "▁d es", "▁C ▁E", "K ▁C▁E", "ed ▁a", "▁A rm", "▁H ▁C", "▁not ▁be▁", "K▁C▁E ▁H▁C", "l it", "n a", "▁1 2", ") (cid:", "w as▁", "▁the▁t reatment", "ob tain", "ing ▁of", "el ig", "pl i", "ir st", "pprov ed▁by", "▁A MG▁162", "ep ort", "ON FI", "- lin", "e ight", "▁d etermin", "▁1 7", "od e▁", "D ENTIAL", "b lind", "l esion", "ONFI DENTIAL", "0 6", "2 2", "s ibl", "▁ \\", "est im", "▁C lin", "i um", ",▁ H", "el et", "stud ies▁", "reat in", "▁th en", ". 000", "P rint", "O G", "um an", "b y▁", "r at", ".\n\n C", "os p", "▁ch ang", "m a", "▁combination ▁with", "- 200", "▁t er", "\n\nD ate▁", "- 5", "e an", "e ach", "o xic", "y l", "▁ radi", "st ate▁", ".▁ J", "cl usion", "stit ution", "ac lit", "▁200 6", "follow -up", "aclit axel", "over all", "e ch", "\n\n 8", "▁A mgen", "ol ution", "d i", "▁n e", "▁ effect", "................................................................ ........", "OL F", "ed▁ or", "▁b oth", "un der", "p anitumumab", "w ell", "▁d et", "▁the▁l ast", "g ress", "in formation", "▁C R", "aborator y", "▁c riteria", "▁in t", "40 54", "sh ip", "ur n", "▁N ▁O", "and ard▁", "g roup", "m ust", "cept or", "X- EGF", "▁T ▁C", ".▁F or", "Clinical▁ Study▁", "ociated▁ with", "3E- MC-", "L ▁Version", "− 201", "▁I ▁N▁O", "▁R ▁T▁C", "▁E▁L ▁E", "GE L▁Version", "▁ID :", ".000 −", "Print ed:", "\n\nDate▁ Printed:", "▁I▁N▁O ▁R▁T▁C", "GEL▁Version ▁ID:", "▁I▁N▁O▁R▁T▁C ▁E▁L▁E", "\n\nA n", "3E-MC- JM", "pproved \n\nDate▁Printed:", "ZD 4054", "on itor", ",▁ B", "7 7", "b y", "s hould▁be▁", "ed▁by ▁the▁", "yp e▁", "fficac y▁", "▁O S", "▁d ec", "s▁of ▁the▁", "or k", "ter n", "OLF OX", "vi ew", "▁ag ent", "it ies▁", "peri enc", "____ ____", "2 7", "▁ •", "▁d iseas", "P FS", "s▁ from", "▁tim e▁", "have▁ been", "3 8", "4 8", "▁a pprov", "▁a vail", "ation al▁", "▁200 8", "▁pl us▁", "\n\nS▁I ▁H▁T", "kn own", "2 8", "▁a ▁c", "es ▁and▁", "C ons", "m un", "l i", "ten sion", "▁ K", ".▁A ll", "▁study▁ drug", "▁ant ibod", "ari abl", "efficac y▁", "SC LC", "▁to t", "qu al", "pr il", "▁s u", "pare d▁", "▁ Y", ".▁ I", "\n\nC onfidential", "( s)", "as sessment", "it iv", "ra m", "\n\nA pproved\n\nDate▁Printed:", "▁med ication", "erious ▁adverse▁event", "e ing", "it e▁", "s▁s hould▁be▁", "▁d iffer", "▁with in", "ard i", "vent ion", "re present", "▁P ro", "▁S ub", "ec k", "str u", ".▁P atients▁", "0 3", "F A", "f re", "st art", "▁b evacizumab", "▁n ew", "/ L", "▁A pril", "▁in creas", "▁D rug", "▁Date: ▁0", "g o", "j ust", "▁this▁ study▁", "med i", "▁Panitumumab ▁Protocol▁Number:▁200", ",▁ G", "EN T", "s▁ on", "ject ive▁", "ir inotecan", "af f", "ic ian", "▁E dition", "e et", "\n\n d▁e▁v▁o▁r▁p▁p▁A\n\nProduct:", "(cid: 120", "ibl e▁for", "m is", "▁in vestigational▁product", "EC IST", "▁ab out", "v isit", "▁A E", "vers us▁", "pt ion", "▁has▁ been", "▁l ung", "c ri", "\n\n L", ",▁ et▁al", "cin oma", "▁c ount", "des ign", "\n\nF ▁O", "ed▁ c", "▁ch emotherapy", "▁F eb", "▁x ▁x", "t reatment", "ing ▁a", "iv er", "▁as sess", "h as▁", "i o", "s ▁and", "\n\n (", "res earch", "▁wh o", "▁min ut", "▁b aselin", "op h", "▁ant i-", "ar e▁", "▁all ow", "op en", ".1 .1", "dur ing▁the▁", "e a", "om en", "▁S t", "- m", "not ▁be▁", "▁also ▁be▁", ",▁ D", "us ed▁to", "our acil", "ist or", "Clinical▁Study▁ Protocol", "d etermin", "▁t rans", "▁p revi", "▁ap plic", "uor ouracil", "▁re view", "su ch", "regn anc", "s▁ at", "▁p art", "▁b y", "l ong", "m Cl", "ire ct", "easur able▁", "▁ every▁", ".2 .2", "with in", "ident ifi", "\n\nY ▁P▁O▁C", "▁accord ing▁to", "C om", "or in", "ing l", "\n\n 5", "▁a ▁m", "des crib", "C on", "J ul", "m ad", "ec ess", "4 5", "c ount", "▁com par", "4 7", "▁pro tocol", "ection :", "\n\nX\n\nX \n\nX\n\nX", "\n\n G", "\n\n s", "▁1 4", "▁n o", "▁per form", "d ay▁", "er g", "com mend", ")\n\n GEL▁Version▁ID:", "▁at ▁least", "M D", "l er", "▁m L", "▁A ppendix", "pl acebo", "em at", "▁D ay▁1", "▁f irst", "R es", "pro v", "uc ov", "- M", "▁ ver", "▁r andomiz", "▁F orm", "ucov orin", "U n", "c er", "d end", "an ib", "afet y", "alysis▁ S", "dend um", "4 3", "v olv", ",▁ L", "▁d evelop", "ir anib", "c ular", "r andomization", "stud ies", "\n\nA ppendix", "umm ar", "s ,▁and▁", "▁the▁ first", "▁b e\n\n", "▁the▁s am", "rel ated▁to", "an alysis▁", "em ia", "am eter", "s▁ prior▁to", ",▁ p", "▁c etuximab", "▁h y", "I C", "f ract", "▁peri od", "\n\n K▁C▁E▁H▁C", "▁c al", "ev i", "reatin ine▁", "C ancer", "d ic", "e▁ will", "▁2 4", "if y", "ub l", "econd ary▁", "Y 23", "▁s ever", "▁un der", "15 14", "bas ed▁on", "ind ic", "Y23 1514", "g rowth", "as h", "uppl ement", "2 1", "8 4", "C ode▁", "▁c oll", "▁D ec", "▁Edition ▁Number", "d iseas", "▁ +", "▁c olorectal▁cancer", "ract ic", "P A", "U M", "- 3", "▁2 01", "▁ass ociated▁with", "▁ph as", "l abel", "reg imen", "itab ine▁", "ivid ual", "I RB", "v is", "▁the▁ event", "iz ed▁", "o h", "e▁ a", "c isplatin", "f ic", "▁p .▁", "as sess", "enc e▁in", "-rel ated▁", "▁I V", "ous ly▁", "mCl one▁", "alysis▁S et", "c aus", "ol ic", "▁toxic ity▁", "p articip", "▁ Q", "▁t wo", "ev id", "ance▁ with", "CT -", "▁ass ign", "sign ificant", "ing ▁and▁", "mit te", "▁for ▁the▁", "D MC", "▁p os", "he a", "require d▁", ") ▁(", ".▁ O", "ed ▁that", "em on", "▁On col", "ubject s▁", "receiv ing", "norm 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"................................................................................................................ ........", "▁chest ▁CT", "extension ▁period▁", "written ▁informed▁consent", ".▁Con comitant", "▁solution ▁for", "▁clinically▁ significant", "profil e▁of", "▁account ability▁", "PT V", "ackgroun d▁", ".▁U pon", "\n\nl \n\na", "▁recommend ation", "early ▁termination", "character istic", "▁att ack", "\n\nCT CAE", "▁the▁informed▁consent ▁discussion", "omin ated▁", ".\n\nAn y▁", "room ▁temperature▁", "eriou s,▁", "▁(Arm ▁A", "\n\nLY231514 \n\nPage▁", "▁has▁not ▁been", "\n\nAbbreviation s:", ",▁as▁well ▁as▁", "Analys es", "\n\n21▁Dec▁2004▁10: 21:", "\n\n21▁Dec▁2004▁10: 36:54", "▁allergic ▁reaction", "e▁from▁baseline▁ in", "Peri od", "▁arch iv", "▁ship ment", "refract ory▁", "ropoi etin", "fib ros", "emov al▁of", "inal▁cor d▁", "blinded▁treatment ▁phas", ",▁placebo -", "cint igraph", "\n\n21▁Dec▁2004▁10:21: 22", "% ),▁", "( 7", "( D", ") ▁on", ", 12", "- R", "- associated▁", "- ▁or▁nail", "/ A", "2 14", "6 th", "8 ▁weeks▁", ": ▁the▁", "A ttachment", "C N", "C ycle▁", "F F", "G PT", "M )", "Q uestionna", "V )", "V F", "Z ometa", "a it", "a uthor", "b one▁scan", "f our", "h n", "k ey", "l u", "s om", "s af", "s olution", "t yp", "v essel", "w indow", "z el", "▁ onset", "▁t eas", "▁t axan", "at al", "\n\n GF", "\n\n analysis▁", "or ▁to", "s▁ R", "s▁ S", "s▁ containing", "s▁ may", "al iv", "it z", "an in", ",▁ investigator", "ed▁ via", "▁an ▁AE", "ic ular", "ic ron", "▁p oly", "▁p oor", "ing ▁placebo", "ing ness▁to", "▁b al", "es ,▁and", "es ▁to▁", "▁s econd", "▁d epend", "▁m ethod▁", "▁m echanism", "om ach", ".\n\n 16", ".\n\n 0\n\n1\n\n2\n\n3\n\n4", "al▁ D", "el ay▁", "▁in crease▁", "es▁ must▁be▁", "es▁ have▁been", "▁P res", "▁( 5-FU", "▁( IVRS", "▁2 1-day▁cycl", "us ed▁on", "▁re cord▁", "ow ski", "▁D uring▁the▁", "▁E ND", "▁or ▁l", "▁or ally▁", "▁or ▁his/her", "\n\nP rior", "qu artil", "od a", "\n\nA BX-EGF", "▁and ▁any▁", "▁O ver", "▁pro duc", "▁N am", "▁R ES", "ed▁in traven", "▁treatment ▁in", ".2 3", "▁is▁ discontinu", "▁al gorithm", "▁al opecia", "e▁s pecific", "▁r un", "▁0 90177e18", "▁3 .2", "▁con junction", ".▁A ccess", "▁the▁s urvival▁", "ave▁ you", "out patient", "▁st eroid", "ing▁the▁ study", "▁6 2", "▁6 .3", "▁4 .0", "▁the▁p anitumumab", "dition al", "s▁( CTCAE", ".4 9", "emother apeutic", "ly ▁available▁", "10 4", "▁tim es", "▁tim e▁for", "ies ▁to", "▁may▁ request", "effect iv", "so ▁that", "s.\n\n 6", "▁Date: ▁20th▁December▁2004", "aborator ies▁", "▁Number: ▁05", "CR O", "25 ▁Edition▁Number", "first ▁met", "\n\nN ▁A\n\nF▁O", "he al", "pre vent", "every▁ 2", "\n\n2 .1", "\n\nR est", "ass umption", "\n\nF ACT-", "\n\n3 .3", "dur ation", "respons ibility▁of", "no ▁less▁than", "▁dose▁ (", "ed▁as ▁target▁lesion", "\n\n4 .1", "data ▁for", "\n\nI ▁have▁", "result ing▁in", "▁min or", "perform ed▁in", "▁sit es", "consider ed", "consider ation", "▁if ▁you", "▁mod ifi", "ed\n\n to", "ed▁s ampl", "val ence▁of", "fficac y▁and▁", "▁Cancer ▁Societ", ",▁200 3", "▁clinical ▁trial▁", "▁must ▁not", "review ▁of", ".▁N ot", "▁chemotherapy▁ is▁", "▁12 .2", "▁both ▁arm", "▁K Ga", "▁this▁study▁ is▁to", "▁Edition ▁Number:▁05", "\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Denosumab▁Protocol▁Number:▁20050244▁Date:▁05▁May▁2008\n\nPage▁", "▁St age▁III", "▁by ▁an", "▁every▁ 2▁week", "Com plet", "▁a▁m ulticenter", "▁first -line▁", "▁hy per", "▁hy persensitivity▁reaction", "Code▁ 7054Il/00", "fic e▁", "olic y▁", ".▁O f", "yn omol", "stor ed▁for", "most ▁frequ", "median ▁PFS", "Clinical▁Study▁Protocol▁Drug▁Subst ance:", "); ▁•", "▁medical▁ histor", "SI DERA", "▁Con comitant", "▁patients▁who ▁are▁", "hyd rogen", "2- week", "▁par affin-embedd", "\n\nth e▁in", "avail abl", "▁further ▁detail", "s▁in▁the▁ ITT", "anu fact", ".\n\nIn ▁addition", "ee▁ Appendix", "plann ed", "whether ▁or▁not", "one▁s cintigraph", "▁Subject s▁with", "▁2005 ;", "▁vitamin▁D 3", ".\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Panitumumab▁Protocol▁Number:▁20050181▁Date:▁04▁April▁2008\n\nPage▁", "▁fl uoropyrimidin", "▁(m CRC", "▁expos ure", "exclud ed▁from", "OT ENTIAL", "alt z", "▁adverse▁ drug", "▁........................................................................................ ....", "▁path ologic", "Phase▁ III", "randomized▁to ▁receive▁", "och ran", "-related▁to xicities▁", "poss ibly▁", "Not e:", "az ol", "y- stimulating▁factor", "▁CON SIDERA", "▁bon e\n\n", "▁suppl ies", "▁Randomiz ed▁", "54I L/0024", ".▁Res ult", ".\n\nH ow", "▁fatty ▁acid▁", "▁analgesic ▁us", "▁70 54IL/0024", "▁adenocarcinoma ▁of▁the▁", "(34)\n\nGEL▁Version▁ID:▁ONC.000−127− 200.3", "(34)\n\nGEL▁Version▁ID:▁ONC.000−127− 199.3", "▁Bicalutamide▁Study▁ Code:", "▁Bicalutamide▁Study▁ Code▁7054Il/00", "▁AND▁D EFINI", "▁bronch ospasm", "manufact urer", "▁ED -SCLC", "TISTICAL ▁METHO", "▁Derivation▁or▁calculation▁of▁outcome▁variabl e", "▁though t", "▁Organ ization", "▁repe at", "▁occurs▁ first", "RAN KL", "▁reasonable▁possibility▁that▁the▁event ▁may▁have▁been▁caus", "equiv oc", "yelos uppression", "utom atic", "erck ▁KGa", "inancial▁ Dis", "▁or▁significant ▁dis", "▁5▁20 ▁December▁2004", "25▁Edition▁Number ▁5▁20▁December▁2004", "▁Edition▁Number:▁05 ▁Date:▁20th▁December▁2004", "ynomol g", "Clinical▁Study▁Protocol▁Drug▁Substance: ▁Bicalutamide▁Study▁Code:", "▁7054IL/0024 ▁Edition▁Number:▁05▁Date:▁20th▁December▁2004", "▁Bicalutamide▁Study▁Code▁7054Il/00 25▁Edition▁Number▁5▁20▁December▁2004", "TISTICAL▁METHO DS", "erck▁KGa A", "Clinical▁Study▁Protocol▁Drug▁Substance:▁Bicalutamide▁Study▁Code: ▁7054IL/0024▁Edition▁Number:▁05▁Date:▁20th▁December▁2004", "( 10", ") ▁was▁", "2 ▁Feb", "6 00", "A ustralia", "D 1", "I mmun", "O xaliplatin", "P O", "T reat", "a ution", "d imension", "g astric▁cancer", "i ▁M", "i ous▁", "k er", "m arrow", "p ic", "p rim", "p oly", "u per", "▁ y▁", "▁ ....................................................................................................", "\n\n from", "\n\n record", "\n\n 20", "\n\n 25", "\n\n information", "▁a mend", "er o", "s▁ until", "re et", "re start", "▁th oracic", "it ch", "▁the▁ appropriate▁", ",▁ di", ",▁ phosphor", "ed▁ during▁the▁", "▁an imal", ".▁ 3", "ing ,▁and▁", "ation ▁with▁the▁", "▁to ▁continu", "▁to ▁participate▁in", "is ▁and▁", "is ▁an▁", "um er", "▁d evic", "▁and▁ 7", "▁in ▁the▁s", "▁in hibit", "ur it", "▁1 :", "▁1 ▁(", "pro per", "▁( SAE", "us ed▁at", "ub mitt", "am ide▁", "form ing", "ther apeutic", "ter o", "\n\nP RI", "▁n g/mL", "\n\nA l", "▁T O", "▁T HE", "▁ad vis", "▁ad mission", "▁R S", "▁R AN", "▁treatment .", ".1 3", "min or", "▁200 401", "▁will▁be▁ ask", "▁will▁be▁ assign", "e▁s ymptom", "e▁s ide▁effect", "▁3 9", "▁com pan", ".▁A ▁copy▁of", "ity▁ for", "▁as▁ need", "as▁ follows:", "▁the▁s ubsequent", "ly▁ s", "s,▁ with", "▁st ain", "will ▁have▁", "▁4 9", "▁the▁p urpos", "▁ac ne", "\n\n1 7", ".5 .3", "med ic", "s▁and▁ SAE", "▁patient s▁and▁", "10 9", "▁the▁d ay▁", "▁G I", "▁U s", "\n\nE GF", "requ ire▁", "s\n\n 7", "roduct ion", "CT SU", "▁10 ▁mg", ".▁In ▁the▁", "s.\n\n 8", "par affin-embedd", "progression ▁of", "▁in▁the▁ absence▁of", "s▁s uggest", "he um", ").\n\n A", ".▁If ▁a", "▁Ad minister", "▁pre -specifi", "▁Study▁ Treatment", "▁a▁s econd▁", "▁the▁l ung", "▁dose▁ escal", "▁reg imens", "e▁b evacizumab", "▁Clinical▁ Oncology▁", ".\n\nS ▁I\n\nS▁I▁H▁T", "ox id", "consider ed▁as▁", "discontinu e▁", "St imulating", "▁do ▁so", "▁occur s,▁", "dis comfort", "yt ic", ".▁N on-", "ext ract", "▁receiv ed▁at▁least", "clinical ▁trial▁", "▁the▁treatment ▁group", "rat e,▁", "under going", ".▁For ▁exampl", "▁dec ide▁", "▁2008 ;", "▁a▁c linical▁", ",▁et▁al .▁A", "identifi er", "▁compar e▁treatment", "▁Appendix ▁Edition▁Number", "▁hy d", "21 ▁days", "▁Ch aracter", "\n\n9 .1", "▁Drug▁Subst ance▁", "at▁least ▁1", "........................................................ .....▁", ":\n\n (cid:120)", "\n\nth e▁s", "echn ical▁", "fficacy▁An alysis▁Set", ".\n\nD ▁E▁T▁N▁I▁R▁P", "▁during▁the▁ study", "pan el", "\n\nV isit", "▁skin ▁cancer", ",▁N o", "ecom mend", "ITT ▁population", "▁such ▁as▁", "FOLFOX 6", "censor ed▁on", "Grade▁ 2", ".▁W e▁", "lig ibility▁", ".▁Wh at", "(cid:13 1)▁", "measured▁ by▁", "Schedul e▁of", "▁Panitumumab▁Protocol▁Number:▁20050181 ▁Amendment▁2", "frequ ency▁", "\n\nC▁I▁N▁O▁R▁T▁C▁E▁L▁E\n\nN ▁A\n\nF▁O", "\n\nPh armacokinetic", "▁........................................................................................ ......", "ed▁in▁a ▁1:1▁ratio", "▁telephone▁ number", "Phase▁ 2", "leas on", "available▁ for", "plain t", "active▁ v", "measurement s▁and▁", "Consider ations", "▁With draw", "▁intraven ous", "\n\nx▁x▁x ▁x", "IRB/ aEC", "▁cent re", "▁to▁ens ure▁", "erm at", "▁prot ection", "▁should▁not ify▁the▁", "▁Radi ation", "phyl actic", "▁advanced▁non- small▁cell▁lung▁cancer", "red▁to ▁as▁", "withhel d▁", "seen ▁in", "▁Europ e,▁", "\n\nMed ical▁", "NCI- CTCAE", "▁predn isone▁", "s▁involv ed▁in", "▁Cont act", "▁Appendix▁D ate▁", "▁under▁the▁ curv", "one▁or ▁mor", "encourag ed▁to", "▁anthracycl in", "▁Lilly▁or▁its▁design ee▁", "▁ret rospective▁", "ordinating ▁investigator", "▁Antibod ies", ".▁Available▁at :▁http://www.", "Fl uorouracil", "itoxant rone▁", "▁lumbar▁spine▁ BMD", "rare ly▁", "osin ophil", "▁CONT ENTS", "▁Day▁1▁of ▁Cycle▁1", "irrespectiv e▁of", "▁is▁responsible▁for▁ensuring ▁that", ".\n\nAppendix ▁XIV▁Page▁", "▁CONSIDERA TIONS", "▁Panitumumab▁Protocol▁Number:▁20050181▁Amendment▁2 ▁Date:▁04▁April▁2008\n\nPage▁", ", ▁there▁", "- 15", "- derived▁", ". org", "/ S", "1 ),▁", "2 )▁and▁", ": ▁In", "; ▁p", "B i", "B est", "C ell", "D UC", "E MENT", "F )", "N ▁A\n\nF▁O\n\nY▁P▁O▁C", "S ubject", "T im", "b lock", "e k", "f ashion", "m ak", "m ethod▁", "m ega", "n ess▁or", "u ish", "v it", "w ild-type▁KRAS", "w ild-typ", "y )", "y ,▁or", "− 77", "▁ ................................", " ▁", "\n\n h", "\n\n Un", "▁a ▁re", "en sion", "s▁ was▁", "re cogn", "st ep", "st ea", "y▁ S", "y▁ for", ",▁ on", ",▁ who", ",▁ until", ",▁ weight", ",▁ oxaliplatin", ",▁ where▁", ",▁ nausea", "ro zen", "▁an ▁increase▁in", ".▁ 16", ".▁ Up", "ar cin", "ed ▁therapy", "es ,▁or", "es ,\n\n", "es s▁of▁the▁", "et y▁of", "▁s erious", "▁s uspect", "as e▁inhibitor", "▁w id", "▁and▁ if", "om ening", "al▁ in", "el ▁J", "▁in itial▁", "▁1 %", "▁C EA", "▁C YP3A4", "▁P T", "▁P art", "pro portion▁of", "▁( K", "▁( 2)", "▁( 32", "con f", "if e▁", "▁S kin", "▁S CCHN", "▁re d▁", "ot ype▁", "ot ension", "un expect", "▁D r", "cl -2", "▁or ▁SAE", "\n\nP emetrexed▁H3E-MC-JMHO(b)▁Confidential\n\nProtocol▁Amendment\n\nPage▁", "per ▁local", "ate▁ or", "▁and ▁about", "▁as ▁to", "ep .", "ef ul", "▁for th", "▁treatment ▁failure▁", "s▁of ▁your", "\n\nS TUDY", "▁of▁ 5%", "e▁s etting", "cor relation", "▁as▁ follows:", "▁this▁ h", "clud e▁", "▁will ▁occur", "▁5 ▁x▁ULN", "▁6 5", "from ▁the▁date▁of▁randomization", "▁subject s▁to", "▁patients▁ have▁", ")\n\n If", "eg er", "continu ed)\n\n", "\n\n1 8", "ept omening", "fer ▁MJ", "ation▁of ▁Addendum", "e▁d aily", "ath eter", "ob il", "▁patient s\n\n", "▁patient s)", "10 2", "▁tim e\n\n", "▁tim epoint", "▁In ▁addition", "▁from ▁all", "vent ory▁", "▁is ▁any▁", "(cid: 14", "▁10 .1", "▁10 ▁minutes", "te bra", "▁x ▁109", "CR PC", "▁us ed▁in", "▁us ed▁for", "▁us ually▁", "\n\nProduct: ▁Denosumab▁Protocol▁Number:▁20050136▁Date:▁30▁April▁2008\n\nPage▁", "al▁pro gression", "every▁ 4▁week", "▁trial s▁", "e, ▁the▁investigator", "sh ortness▁of▁breath", "▁day s▁(", "ically▁ documented▁", "e▁b efore▁", "fl uor", "▁act ual▁", "in▁the▁ absence▁of", "sign ificance▁level", "▁sampl e▁siz", ".▁R e", "ann a", "ann ed▁M", ".▁200 6", "\n\nH a", "St age▁III", "St opping", "▁sub -", "▁ind ividual▁", "\n\n6 .3", "▁provid es", "▁response▁ assessment", "RO DUC", "efit inib", "urg ical", "ext end", "\n\nB evacizumab", "▁follow-up ▁visit", "▁to▁ estim", "ry▁ skin", "▁document ation▁of▁", ".▁E▁S▁U \n\nE▁R▁O▁F▁E▁B", "▁Clin ical", "▁chang es", "▁2006 ▁15", "▁su it", "FA CT", "▁increas ing", "design e", "▁minut es,▁", ",▁p elvis", "▁sever 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"▁I mClone▁", "▁re ference▁", "ag e.\n\n", "ow der", "▁D ES", "▁D HA", "▁h e/", "▁h e▁or▁sh", "▁l aborator", "ap hragm", "▁E NR", "▁f ax", "e▁t otal", "\n\nP lacebo", "ex ternal", "ex ▁Cor", "\n\nA m", "\n\nA \n\nS▁I\n\nS▁I▁H▁T", "\n\nA LT", "\n\nA ▁Randomized,▁", "▁O utcom", "▁pro pos", "▁T R", "up press", "▁N ▁A", "ep s", "▁for ▁treatment", "▁R ationale▁for", "e\n\n E", "ed▁in fection", "▁treatment ▁until", "ed▁to ▁Amgen", "ed▁to ▁have▁a", "ort on", "og -rank▁test", "ant i", "\n\nS AE", "▁that ▁your", "▁is▁ defined▁as▁", "▁of▁ other", "e▁s afety▁", "e▁s uch", "▁M on", "▁of▁the▁ trial", "e,▁ ALT,▁AST", "▁F ail", ".▁A ppro", ".▁The▁ hazard▁ratio", "▁the▁s econdary▁", "ated▁ (", "int ens", "▁B oth", "▁B reast▁Cancer", "▁all ▁of▁the▁", "ip ment", "▁will ▁include▁", "eff icient", "will ▁remain", "▁6 9", "▁H ER", "▁4 00▁IU", "▁the▁in formed▁consent▁form", "▁ac ross", "continu ed)", "ident ify", "vi al▁", "s.▁ E", "s.▁ M", "s.▁ W", "cons ult", "med icin", "ally▁ con", "e▁d es", "▁patient ▁will▁be▁", "▁patient s▁are▁", "10 8", "s▁will▁be▁ performed▁at", "ies▁ of▁the▁", "report ed▁in▁the▁", "▁J oint", "GF -", "▁In ternational▁", "ed▁by▁ C", "▁may▁ lead▁to", "▁month s▁for▁the▁", "pres ence▁of", "CT ▁or▁MRI", "(cid: 12", "(cid: 100)", "▁adverse▁event s\n\n", "▁per mission", "e▁v ial", "includ ed▁", "▁10 .4", "so hn", "arg in", "record s,▁", "over ▁tim", "▁cont ribution", "▁ab stract", "20 ▁mg", "investigator ▁should▁", "▁8 .5", "▁8 ▁hour", "ppend ic", "every▁ 6", ".▁If ▁a▁subject", "\n\n2 .2", "▁form s▁will▁be▁", "▁lesion s▁", "\n\nR ational", "▁Study▁ Endpoint", "present ed▁in", "present ▁at", "\n\nT ABLE▁OF▁CONTENTS", "On ly▁", "▁the▁patient ▁has▁", "ER C", "\n\nY our", "\n\nY ES", "KRAS ▁Efficacy▁Analysis▁Set", ".\n\nA t", "e) ▁and▁", ".▁F OLFIRI", "▁day s▁(±", "le ast", ".\n\nP anitumumab", "e▁b reak", "hy per", "▁therapy▁ in", "including ▁a", "e▁treatment ▁with", "199 8", "etw ork", "An ti-", "▁evalu ated▁in", "provid ed▁in▁the▁", "ack ▁of▁", "▁the▁study▁ is▁to", "▁sampl e▁for", "▁sampl e▁will▁be▁", "▁the▁subject ▁or", "▁dose▁of ▁investigational▁product", "appro ach", "ed.\n\n D", "ed.\n\n In", "▁et▁al ▁19", "▁if ▁the▁", "▁if ▁it", "▁if ▁this▁h", ".▁B reak", "eb rovascular", "dis s", ",▁s uppl", "ha uer", "s▁will ▁includ", "week ly", "▁survival ▁and▁", "▁hour s▁after", "administer ed", "sub group", "\n\nIn clusion▁Criteria", "▁activ e▁treatment", "\n\nB aselin", "conduct ▁of", "part ial", "uthor ship", "▁until ▁PD", "OS E", "▁there▁ a", "▁document ation", "22 :", "estim ate▁of", "estim ated▁that", "follow-up ▁information", "under gone▁", ",▁B l", "▁dec rease▁", "▁approv al▁from", "▁antibod y▁(", ".▁I maging", "s▁should▁be▁ performed▁", "▁bevacizumab ▁and▁", "▁chemotherapy ▁and▁", "research ▁study▁", "oph osph", "▁St age▁IV", "istor y▁of", "determin ation▁of", "▁trans cription", "▁part ▁of", "describ ed▁abov", "\n\ns ymptom", "▁Day▁1 ▁of▁each▁cycl", "cer al", "\n\nAppendix ▁C", "s,▁and▁ other", "▁Q u", "erv ic", "expect anc", "ycle▁ 1", "\n\n9 .3", "▁15 ▁mg/kg", "fi ed▁with", "▁measurement s▁", "chemotherapy ▁and▁bevacizumab", "HR QoL", "Ex ploratory▁", ".,▁et▁al.,▁ M", "evaluation ▁or", "\n\nt ime▁to", "recommend ed▁for", "ourc e:", "central▁ review", "central▁ radiology▁review", "46 2", "measure d", ".\n\nE X", "MENT AL", "Assessment s▁", "▁100 ▁x▁109/L", "FACT- Fatigu", "por ation", "olum e▁of", "▁valu e▁of", "▁tel omere▁length", "epar ately▁", "▁2000 ;", "opt otic", "medical▁ institution", "statist ically▁significant", "▁bi ologic", "Pl eas", "▁Ex tension", "▁was \n\n", "▁Efficacy▁An alysis", ")▁in ▁patients▁with", "▁PRO TOCOL", "▁indic ator", "ITT ▁Efficacy▁Analysis▁Set", "▁2004 ;", "met a-", "chest ▁CT▁scan", "▁due▁to ▁any▁caus", "▁alon e.\n\n", ".\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Denosumab▁Protocol▁Number:▁20050244▁Date:▁05▁May▁2008\n\nPage▁", "▁et▁al.▁200 5)", "▁demonstr ating", "▁demonstr ate▁a", "▁4▁week s▁of", ".\n\nN ot", ".\n\nN ▁A\n\nF▁O", "▁en hanc", "▁alone▁ as", "risk▁of ▁death", "▁Study▁D rug", "▁availabl e)", "rict ed▁in", "▁Therapy▁ for", "stopp ed▁", "▁compared▁to ▁placebo", "▁path way", "▁add res", ".▁( for", ".\n\nWh o", "expos ure▁to", "▁ext ent", "Data ▁Collection", "▁ha zard▁", "sever ity", "etc .", "Response▁ System", "▁return ed▁to", "▁systemic ▁anticancer▁therapy", "measurement ▁of", "us▁of ▁0", "▁this▁research ▁study▁", "▁they ▁are▁s", ",▁V an", "ethod▁of ▁assessment", "▁the▁interim ▁analysis", "RT K", "dat es▁of", "participation ▁in▁the▁study", "cr as", "▁intraven ous▁infusion", "fil ter", "▁as▁well ▁as", "▁receiving ▁panitumumab", "-L ine▁", "▁small -cell▁lung▁cancer", "light ly▁", ",▁v omiting", "▁cent r", "▁1.5 ▁x▁ULN", "▁pharmac ist", "fin anc", "eam ▁Physician", "▁will▁be▁used▁to ▁compare▁treatment", "▁calcul ate▁the▁", ",▁al though", "omet im", "quant itative▁", "▁commer cially▁available▁", "Investigator’s▁ Brochure", "Form ulation", "▁AUC ▁6", "▁sufficient ▁shrink", "▁Evalu ation", "approv ed▁", "▁platinum -based▁", "MP LE", "▁Cycl es▁", "efficacy▁and▁ safety", "▁the▁inter action", "\n\nAmgen▁Thousand▁Oaks \n\nConfidential\n\nAMGEN\n\nProduct:▁darbepoetin▁alfa▁Protocol▁Number:▁20010145▁–▁Amendment▁2▁Date:▁16▁July▁2004\n\nPage▁", "acceptable▁to xicity▁", "▁should▁not ify▁", "▁blinded▁ study▁medication", "▁(Arm ▁B", ",9 ,10", "▁will▁continu e▁to▁be▁", ".▁Com par", "▁profil e▁of", "el: ▁+", "s▁and▁the▁ proposed▁mechanism▁of▁action", "▁x▁x▁x▁x ▁x▁x▁x▁x", "discuss ed▁with", "UBJEC TS", ".▁Clin ▁Cancer", "▁will▁be▁perform ed▁to", "followed▁until ▁resolution", "▁Dose▁Modification s▁for", "d▁and▁ Signific", "s▁occurring ▁at▁the▁sit", "▁Ep idemi", "E▁S▁A▁E▁L▁P \n\n.▁T▁N▁E▁M▁U▁C▁O▁D", "apable▁of ▁only▁limit", "intraven ous▁infusion", "e▁indic ate▁", ".▁New ▁York", "VESTIG ATOR", "recommendation s▁for", ".\n\nE▁R▁O▁F▁E▁B \n\nY▁T▁I▁D▁I▁L▁A▁V", "orld▁ Health", "▁x-ra y▁", "▁interfer e▁with", "▁acut e▁", "bal anc", "▁larg e▁", "▁lo ok", "▁mm▁with ▁spiral▁CT▁scan", "every▁6▁month s▁for", ".▁Further mor", "▁total▁hip ▁BMD", "ranulocyt e▁", "▁Clinical▁Onc ology", "▁missing ▁data", ",▁An ti-Panitumumab", "cho os", ".▁Ann ▁Oncol", "▁creatinine▁clear anc", "gene▁ expression", "▁diet ary▁", ".▁Journal▁of ▁Clinical▁Oncology,▁", "objective▁of ▁this▁study▁is▁to", "effect▁of▁ZD4054 ▁in▁combination▁with▁docetaxel▁on", "Histor y", "particular ly▁", "idney▁ ston", "▁the▁treat ing▁physician", "\n\nPRO TOCOL", "▁arth rit", "mg/m2 ▁IV", "±▁3 ▁days", "capture d▁", "pG ▁is", "▁medicin al▁product", "gestive▁heart ▁failure", "stimated▁ Study▁D", "▁sensitiv ity▁to", "ity▁Ass urance▁", "e-bas ed▁", "origin al▁protocol", "ois otop", "▁teas poon", "▁taxan e▁", "prim arily▁", "Stimulating ▁Factor", "ecommend ation", ".▁Up ▁and▁about", "conf idence▁interval", "SSESS MENTS", "▁sponsor- nominated▁", "ref riger", "jeopard iz", "▁causal▁relationship ▁with", "▁e▁e▁ k", "▁Arm▁A▁and▁ Arm▁B", "▁PATI ENTS", "3)▁(cid: 4)▁(cid:", "dys cras", "▁phys ically▁", "▁to▁zoledronic▁acid▁ with", "rosatellit e▁in", "EAS URE", "endel sohn", "(34)\n\nGEL▁Version▁ID:▁ONC.000−127−200.3.0\n\nApproved\n\nDate▁Printed:▁31−Jul−2014\n\nApproved▁by\n\n21▁Dec▁2004▁10:21:22 \n\nAmended▁Clinical▁Study▁Protocol▁Bicalutamide▁Study▁Code▁7054Il/0025▁Edition▁Number▁5▁20▁December▁2004", "▁lat er▁than", ".6.6 ,▁Anti-Panitumumab", "desir able▁", "5)▁(cid: 6)▁(cid:", "melanoma ▁skin▁cancer", "axoter e", "▁limit▁of▁normal▁( ULN", "intiles▁L aboratories▁", "throm bin", "▁36\n\nSection:▁2.3 .6.6,▁Anti-Panitumumab", "eclaration▁of▁Helsink i", "NOP SIS", "▁DES IGN", "▁ENR OLL", "apable▁of▁only▁limit ed▁s", "stimated▁Study▁D uration", "▁36\n\nSection:▁2.3.6.6,▁Anti-Panitumumab ▁Antibodies", "% ▁of▁the▁", "% ,▁respectively", "( B", "( 12", ") ▁may▁be▁", "+ /-", "- lik", "1 40", "6 ,▁12", ": 15", "A Z", "B SA", "C ONFIDENTIAL", "C reatinine▁Clear", "D ouble-", "E TIC", "G emcitabine▁", "G leason", "J ,▁G", "J ,▁K", "L A", "M aster", "O ver", "O ST", "P T-11", "S erious▁Adverse▁Event", "T ime▁to", "V C", "V ER", "W ,▁S", "Y es▁or▁No", "a ▁D", "a ▁bit", "b e", "b u", "c ovariates", "e ous▁", "f oc", "f all", "f ix", "f acil", "f uture▁", "f unding", "g a", "h in", "j acent", "k eys", "l ev", "p otentially▁", "r ace", "r are▁", "s a", "s qu", "s ▁through", "t ime▁to", "y toch", "▁ −", "▁ eas", "▁ ever", "▁ outlin", "▁ esophag", "e▁ p", "in avir", "▁t ast", "at es▁(", "at ▁screening", "at e▁transamin", "on ic", "on e▁of▁the▁", "\n\n and", "\n\n OS", "\n\n analysis", "▁a ▁1", "▁a ▁non-", "▁a void▁", "or \n\n", "or d▁", "s▁ –", "s▁ using", "re e-", "▁th or", "▁th us", "▁th yroid▁", "st age▁III", "it ate▁", "it al▁or", "▁the▁ other", "▁the▁ right▁to", "of ▁Consent", "an alyt", ",▁ follow-up", ",▁ based▁on", "ro ad", "ed▁ up", ".▁ Protocol", "ar ine▁", "▁p otentially▁", "▁c av", "▁c ourse", "▁b lack", "es ▁as▁", "es ,▁a", "ation ,▁or", "▁to ▁evaluate▁the▁", "▁to mograph", "as ons", "▁of ▁approximately▁", "▁of ▁paclitaxel", "▁of ▁cycles▁", "um ▁LD", "▁d ipstick", "▁w ound▁", "▁and▁ not", "▁and▁ your", "▁and▁ weight", "▁and▁ post-", "ect ib", ".\n\n d▁e▁v▁o▁r▁p▁p▁A", "is▁ F", "▁A cid", "▁A LT", "▁in ▁10", "▁in ▁the\n\n", "................................ ....", "................................ ......", "ur witz", "ev ident", "oc rin", "pl ant", "▁C 1", "▁C arcinoma", "es▁ it", "▁P olicy", "▁P ART▁B:", "pro gn", "▁( ±", "▁( not", "▁( to", "▁( LD", "▁( longest▁diameter", "▁( Version▁3.0", "▁S ci", "▁S ummary▁of", "▁S ▁I\n\nS▁I▁H▁T", "▁re productive▁", "▁re asons", "ot ally▁con", "un n", "▁D FS", "▁D eath", "cl ose▁", "ap pe", "▁E B", "▁E nd", "▁f ib", "▁or ▁T", "▁or ▁greater", "e▁t ub", "▁n ail", "od ay", "\n\nA ST", "▁T arget", "▁ad ding", "▁N OT", "op oul", "will▁be▁ analyz", "▁ar rest", "▁for ▁genetic▁research", "▁R PLS", "enc od", "ed▁to ▁your", ".1 6", ".1 7", ".1 .4", ".2 \n\nStudy▁", "▁with hold", "▁with ▁zoledronic▁acid▁", "ed▁b oth", "s▁of ▁blood▁", "s▁of ▁22▁March▁2007", "▁that ▁tim", "▁that ▁may▁be▁", "▁200 3;", "▁will▁be▁ used▁for", "▁M C", "▁3 -week", "▁con stitut", "cor related▁", "event ▁that", "▁of▁the▁ first", "▁o ▁t", ".▁The▁ Investigator", "▁as▁ direct", "▁as▁ specifi", "▁g iv", "▁on ▁all", ",▁and▁ 1", ",▁and▁ at", ",▁and▁ bevacizumab", "ine▁ needl", "▁L Y231514", "▁this▁ is▁", "s,▁ bas", "s,▁ CA", "▁all el", "▁all ▁pre-", "\n\nC etuximab", "▁ch arg", "ing▁the▁ protocol", "▁5 4", "▁6 ▁mg/kg", ")\n\n M", "▁the▁in vestigational▁", ".4 1", ".4 2", ".4 6", "continu e▁", "continu ous", "ident ification", ".5 %", "s.▁ Ex", "▁any▁ in", "▁any▁ subject", "▁V itamin▁B12", "▁the▁t arget▁lesion", "\n\nD elete:", ".▁S erum", "▁the▁d eath", "▁G A", ".▁P FS", ".▁P leas", "▁is ▁allow", "ial▁ lung", "mon ocyt", "str enu", "s) ▁will▁be▁", ".6 .3", "▁to▁the▁ efficacy▁of", "▁assessment s▁(", "▁ag onist", "▁ph osph", "record ing", "s.\n\n 3", "te omic", ".▁T otally▁con", ",▁or ▁death", ".,▁ M", "▁8 8", "e▁( IEC", "15 00", "every▁ 4", ".7 2", "▁form ▁used", "ular ▁fil", "Study▁ Medication", "▁has▁ returned▁to▁baselin", "▁a▁s chedul", "▁cycl e\n\n", "e, ▁the▁patient", "dur ing▁screening", "ER MI", "▁the▁l ow", "▁inter pret", "▁reg istration/", ".\n\nA D", "▁day s▁or", "▁day s▁before▁", "uc oc", "data ▁on", "e▁b etween", "pri ateness▁of", "▁panitumumab ▁in▁combination▁with", "s▁or ▁to", "▁Clinical▁ Research", "▁death ,▁", "d▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Denosumab▁Protocol▁Number:▁20050244▁Date:▁05▁May▁2008\n\nPage▁", "▁evalu ating", "enter al", "ed▁from ▁Amgen", "▁cell ▁lin", "JM HO", "appro val▁", ",▁P a", "randomiz ed▁in▁a▁1:1▁ratio", "y▁and▁ capable▁of▁all▁s", "▁CT ▁or▁MRI", "e▁that ▁is▁", ".▁B i", ".▁B y▁", "response▁ and▁", "number ,▁", "ed▁s lid", "▁Page▁ 1", "................................................ ...▁", "▁disease▁progression ▁is▁", "ros ome▁", "-t elop", "▁dis cretion", "▁dis crepanc", "▁drug s▁", "▁dur ation▁of▁", "▁dur ing▁or", "▁loc ation", "administer ed▁in", "man ual", "man uscript", ".▁An y", "\n\nIn ternational▁", "▁respons ible▁person", "part ▁of", "▁until ▁the▁", "ogen ous▁", "RE G", ")(cid: 10", "obtain ed▁", "\n\n8 \n\n9", "▁Amgen ’s▁", "by ▁a", "s▁should▁be▁ select", ".▁Patients▁ will", "▁increas e▁the▁", "▁count ri", "\n\n( continued)\n\n", "▁who ▁are▁", "▁baselin e▁of", "determin ed▁", "▁a▁m ean", "Con comitant▁Medication", "▁protocol ▁procedure", "▁mL ▁of", "▁develop ed▁", "▁the▁first ▁day▁of", "▁the▁sam e▁tim", "▁+ /-", "▁phas e,▁", "particip ation▁in", "▁Q Tc", ".\n\nT umor", "▁15 72", "▁confirm ation▁of", "▁withdraw n", "▁withdraw al▁of▁consent", "andomis ation", "ral gia", "▁hav e\n\n", "▁18 ▁years▁of▁ag", "pens ation", "▁long -term", "▁safety▁ concern", "median ▁OS", "analys es", "Treatment ▁of▁", "study▁drug ▁administration", ",▁W ang", "ate▁th at▁the▁", "\n\n10 .1", "reduction ▁in", "▁time▁to ▁clinical▁progression", "▁period▁ for", "▁accept able▁to", "▁accept able\n\n", "2- hour", "▁caus ality", "\n\nth e▁subject", "▁its▁ representativ", "\n\nin fusion", "▁am bulator", "▁meet ▁the▁", "▁days▁after ▁the▁last", "rac ellular", "▁amendment s,▁", "▁amendment ▁3▁–▁dated▁23", "gl ucos", "ison ▁of", "▁vari ous", "▁valu es▁", "respectiv ely▁", "epar in", "▁conduct ▁of▁the▁", "statist ical▁", "▁consider ation", "▁Ex clusion▁Criteria", "\n\nd eath", "omit ing,▁", "▁treatment▁with ▁panitumumab", "ing▁p uls", "▁> ▁2", "remain s▁", "▁whether ▁or▁not", "staff ▁will", "Stat ement", "e▁the▁s afety▁", "\n\nAmgen ▁Inc", "▁chest ,▁abdomen", "▁Patient ▁Reported▁Outcom", "stitutional▁ review▁board", "\n\nTable▁ 3", "▁the▁treatment▁of ▁patients▁with", "should▁ not", "measured▁ from▁the▁date▁of▁randomization", "\n\nSt op", "LIN ICAL", ".▁Patient ▁has▁", "▁blood▁sampl e▁will▁be▁", "emor adi", "▁appear s▁to▁be▁", "▁(cid: 13", "▁add ed▁to", "▁of▁your ▁cancer", "required ▁to▁be▁", "lymph ▁node▁", "▁regard ing▁the▁", "▁written ▁informed▁consent", "sever ity▁of", "▁Dos age,▁Administration", "▁administration▁of ▁investigational▁product", "▁estim ate▁the▁", ".▁Thes e▁data", "▁lin e▁treatment", "▁strati fication▁factor", "▁the▁discretion▁of▁the▁ Investigator", "▁................................................................................ ..", "e▁test ing", "ful fill", "grade▁ 4", ".▁Pro ceeding", "stable▁ angina", "▁AD VERSE▁EVENT", "Modification s▁for", "Not ification", "’s ▁treatment▁assignment", "▁........................................................................ ......", "▁on-study▁ chemotherapy", "version ▁of▁the▁", "ID MS", "\n\nNot ▁applicable▁to▁amended▁protocol", "▁or▁s edent", "ass▁ vial", "▁Respons e", "▁cent ral", "participating ▁in", "-to -", "quant ity▁of", "▁att empt", "▁appropriat e.\n\n", "neutrophil s,▁", "onc e▁", "▁Man ual", ".▁Phase▁ III", "▁measurable▁ lesion", "▁respon d", "▁months▁after ▁the▁last", "evidenc e▁that", "pne umon", "al▁s urv", "\n\nAmended▁Clinical▁Trial▁Protocol▁5▁XRP6258/EFC6193\n\n21-Jul-2008▁Version▁number:▁1▁(electronic▁2.0 )", "▁anticip ated▁that", "reported▁to ▁Amgen", "▁discontinuation▁of ▁treatment", ".▁Ch emotherapy▁", "weekly▁ for", "▁tr end", "war e▁of", "whichever ▁occurs▁first", 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ost", "Q U", "R ad", "S uppl", "T M", "V A", "W HO", "X AL", "[ plasma▁and▁", "] ,▁and▁", "] .▁In", "a xim", "a verage▁", "b ag", "c orticosteroid", "d on", "d re", "d ipstick", "e er", "e .▁All", "g ive▁", "h arm", "h ttp://", "i j", "i ation", "j un", "n ever", "n ell", "n onsquamous▁", "o al", "o ok", "s em", "s urg", "s ingle▁", "w ide▁", "w arrant", "y alg", "° F", "± ▁15▁minutes", "▁ 00", "▁ effort", "e▁ 1", "e▁ has▁been", "in ic", "in crease▁", "in formed▁of", "▁t rough", "▁t roponin", "at inib", "at zem", "\n\n ac", "\n\n event", "\n\n Version", "\n\n Qu", "▁a pproved", "en al▁", "en rolment", "s▁ report", "s▁ consent", "s▁ relevant", "y▁ A", "y▁ b", "y▁ stimulating▁factor", "ent an", "it ing", "▁the▁ AE", ",▁ sign", ",▁ non-", "▁an ▁SAE", "▁an ▁objective▁", "▁an ▁ongoing", "ic ▁attack", ".▁ 10", ".▁ 11", "▁c erv", "ing ▁about", "for ▁at▁least", "et ]", "et ary▁", "et ention", "▁to ▁assess", "is sing", "▁of ten", "um atic", "▁d er", "▁d evi", "▁d examethasone▁", "▁d raw", "▁w 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"▁the▁s erum", "▁on ▁study", "ated▁ lung", "ated▁ fatty", "ine▁ and▁", "int ensity▁", "s,▁ S", "s,▁ respectively", "12 3", "ip s", "▁st ill", "▁st abiliz", "▁ch emotherapeutic", "▁will ▁include▁a", "e▁in volv", "▁5 00▁mg/m2", "▁5 ▁years▁of", "▁6 ▁1", "▁6 .3.1", "cur ric", "▁subject s▁treated▁with", "▁4 %", "▁the▁p emetrex", "▁ac cident", "eg o", "eg e▁of", ".4 4", "continu ed▁until", ".5 1", ".5 8", "s.▁ You", "▁week s)", "rit ical", "▁any▁ purpose▁", "▁ex clud", "ell ow", "ell et]", "ance▁ and▁", "▁wh il", "ed▁by ▁the▁patient", "eth otrex", "ally▁ related▁to", "ed▁for ▁a", "s▁and▁ Study▁T", "e▁d ail", "▁patient s,", "ang itis▁", "▁G ▁M", "▁un used▁", "ous ework", "▁U PCR", "e▁the▁ right▁to", "pt s)▁with", ".▁P ower", "s\n\n For", "ed▁by▁ each", "evalu ating▁the▁", "▁tumor ▁lesion", "▁tumor ▁imaging", "effect ▁on", "▁study \n\n", "▁study ▁therapy▁", "artic ulate▁", "s) .", "pp ear", "record ed▁and▁", "record ing▁of", "s.\n\n 5", "s.\n\n D", ",▁and ▁that", "▁sign ▁this▁", "RI MENTAL", 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▁sit", "▁blood▁ [plasma▁and▁", "▁result s▁of", "arget▁lesion s▁should▁be▁select", "IN TS", "IN VESTIGATIONAL▁PRODUCT", ".▁N on", "\n\nB aseline▁", "\n\nB iomarker", "given ▁at", "part ate▁transamin", "uthor ization", "rati fication", "▁tissu e▁block", "chang es", "chang es▁to", "ry▁ (", ")(cid: 3)(cid:", ",▁H ean", ".▁J ournal", "di ent", "▁ne uropath", "ed▁or gan", "▁both ▁treatment▁arm", "▁int ens", "▁int ellect", "ed▁by▁the▁ following", "▁approv ed▁informed▁consent▁form", "known ▁as▁", "▁a▁c or", "ed▁c ycl", ",▁D ay▁1", "▁previ ous", "▁every▁ 21▁days", "Un der", ",▁L ang", "▁develop ment▁of", "\n\nAppendix ▁B", ",▁p ower", "▁cetuximab ▁infusion", "▁period ic", "caus al▁relationship", "▁two -sided▁", "▁KRAS ▁status▁", "study▁treatment ▁period▁or", "chemotherapy▁ (", "▁research ▁study", "▁of▁a ▁light▁or▁sedent", "▁health y▁", "▁health care▁", "▁health ▁care▁", "▁health -related▁quality▁of▁lif", "IG IB", "▁author ization", "▁and▁s cientific", "▁20 ▁mg", "erious▁ or", "eph er", "during 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ed▁log-rank▁test", "stopp ed▁for", "▁Rec ord", "ogenic ity▁", ".▁The▁investigator ▁should▁notify▁the▁", "delay ed▁for", "▁IN FORM", "▁ext raction", "\n\nPage: ▁36\n\nSection:▁2.3.6.6,▁Anti-Panitumumab▁Antibodies", "▁statist ic", "▁specific ally▁", "▁Dos age▁Adjustment", "\n\nPatients▁ who", "▁this▁research .▁Neither▁Amgen", "▁chemist ry,▁", "▁EGFr ▁expression", "e▁on ▁a", "▁well -being", "recorded▁on▁the▁ case▁report▁form", "▁predict ive▁", "s▁must ▁not▁be▁", "▁assess▁the▁ effects▁of", "prior▁to▁the▁ first", "version ▁3.0", "▁rate▁ (", "\n\nNot e:", ".▁Patients▁who ▁are▁", "▁5-fluorouracil /", "igen etic", "=0 .0", "hibition ▁of", "e▁dis comfort", "EL L", "▁consist s▁of", "▁and▁E arly▁Stopping", "▁calcul ate▁", "▁thromb osis", "starting ▁dose▁of", "lood▁sampl es▁will▁be▁", "lic ens", "▁plasma ▁concentration", ".▁Phase▁ II", "▁sufficient ▁increase▁to", "box ▁number", "flu id▁", "\n\nWh at", "▁grad ing", "▁mis s", "e▁as pir", "▁experience▁ any▁", "▁3.3 .4", "fail ure", "▁fever ▁or", "▁stratifi ed▁by▁the▁randomization", "ed▁before▁ any▁", "statistical ▁analysis▁plan", "▁investigational \n\nproduct", "ed▁in▁accordance▁with ▁the▁", "adjusted▁ HR", ".▁It▁is▁ recommended▁that", "PE RIMENTAL", "withhel d▁for", "▁select ed▁", "▁activities .▁Up▁and▁about", "▁Investigational▁Product ▁for▁Destruction", "▁and▁c ardiovascular", ".\n\nTh ere▁", "s▁per ▁organ", "omat itis▁", ",5 ,6", "▁ren al▁cell▁carcinoma", "▁apopt osis", "▁aged▁ >", "should ▁also▁be▁", "▁previously ▁treat", "▁previously ▁treated▁", "(6 ):▁p.▁", "omer ular▁filtration", "performed▁as▁ clinically▁indicated", "recent ly▁", "▁arch ival", "hold▁ dose▁until▁toxicity▁", "United▁St ates▁", "(5 ):▁p.▁", "▁ml /min", "amount ▁of", "entered▁into ▁the▁study", "European ▁Union", "▁unable▁to ▁carry▁out", "blinded▁ study▁medication", "goal ▁of▁the▁", "▁qualify▁for ▁PD", "pa id▁", "▁the▁prior ▁written", "we ak", "▁Discontinu ation▁of", "▁proc es", "▁Lilly▁or▁its▁design e", "▁all▁randomized▁ subject", "reported▁as ▁adverse▁event", "Ac adem", "▁radiograph ically▁documented▁PD", "▁Metastatic ▁Colorectal▁Cancer", "double-blind ,▁placebo-", "▁tra il", ",▁pleas e▁", "▁1999 ;", "has▁not ▁been", "loride▁ Injection", "\n\nS▁T▁I\n\nK▁C▁E▁H▁C\n\nE▁S▁A▁E▁L▁P\n\n.▁T▁N▁E▁M▁U▁C▁O▁D \n\nC▁I▁N▁O▁R▁T▁C▁E▁L▁E\n\nN▁A\n\nF▁O\n\nY▁P▁O▁C\n\nD▁E▁T▁N▁I▁R▁P\n\nA\n\nS▁I\n\nS▁I▁H▁T", "▁EL IGIB", "reconstruction ▁interval▁", "thical▁ Review", "▁24-hour ▁urine▁collection", "terim▁Analysis ▁and▁Early▁Stopping", ".\n\nRE FERENCES", "ed▁but ▁not", "▁controll ed▁", "▁and▁Treatment ▁Schema", "age▁to ▁qualify▁for", "▁prescrib ing▁information", ".▁1999 ;", "▁fully▁ human", "moder ate▁", "objectives▁of ▁the▁study", "categor iz", "ossibl e▁", "▁the▁differ ence▁in", "ed▁onc e▁", "PACCE ▁protocol", "▁compliance▁ is▁", "respiration ▁rate", "▁progn osis", "▁Roch ester", "s▁- ▁Other", "▁dig it", "thir d▁", "▁3rd▁ quarter", "▁a▁sec ure▁", "▁between▁the▁2 ▁treatment▁arm", "▁run -in", "fice▁ work", "most▁frequ ently▁", "▁adverse▁drug 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"\n\nX\n\nX\n\nX\n\nX \n\nX", "▁randomiz ed▁to", "alysis▁S ubset", "\n\nAppendix ▁X", "analysis▁ of▁the▁", "▁hy po", "▁hy percalcemia", "fract ur", "dic tion", "indic ator", "▁+ 1", "ing▁and▁ Data▁Collection", "DMC ▁member", ".▁O xaliplatin", "ing▁s ystem", "▁the▁b lood", "▁Ph ysical▁Examination", "rof il", "▁and▁s afety▁", ",▁R os", "▁overall ▁survival▁(OS", "▁docetaxel -based▁chemotherapy▁regimen", "\n\n13 .1", "▁prior▁to ▁disease▁progression", "Pro of▁of", ".,▁et▁al.,▁ C", "▁they▁ have▁", "ecaus e▁th", "PD GFR", "RP C", "mor e▁frequ", "measure d▁and▁", "▁Med DRA", "wer e▁d", "▁days▁after ▁the▁last▁dose▁of", "ulti plic", "representativ es▁from", "FACT- B", "serum ▁calcium", "▁are▁not ▁limited▁to", "pers ons", "ed▁m ethod", "e▁P anitumumab", "▁cisplatin ▁plus▁", "AT E", "atch ful", "▁conf in", "▁risk ▁reduction", ",▁N ew", "▁ ▁", "on▁the▁ CRF", "▁marker s▁of", "▁performance▁stat us▁", "▁man ual", "censor ed▁using▁the▁", "▁carboplatin ▁infusion", "▁subjects▁who ▁have▁", "resolv ed▁to", "pharmac y▁", "▁applicabl e▁sit", ".\n\n2 .3", "procedures ▁and▁", "procedures ▁are▁", "option al▁", "second ary", "Evalu ations", "272−636.4 .0", "hel d▁for", "▁To ▁be▁", "▁any▁other ▁reason", "▁reduc ed▁", "▁alone▁ or", "ate,▁ BUN", "▁discontinuation ▁from▁study▁treatment", "▁termin ate▁the▁", "ed▁according▁to ▁treatment", "\n\nW BC", "schedul e▁of", "▁Per form", ",▁O '", "EP LAC", "rect um", "work ▁activities.▁Up▁and▁about", "assign ment", "see▁ Table▁", "▁pemetrexed▁ plus▁cisplatin", "objective▁ progression", "judg ed▁to▁be▁", "▁March ▁2006", ".▁Ex clusion▁Criteria", "▁Follow ed▁by▁M", "delay ed▁until", "▁contact ▁with", "used ▁throughout▁the▁study", "▁Ac cess", "▁you▁are▁ pregnant", "▁use▁ an", "▁work ▁of▁a▁light▁or▁sedentary▁n", "▁Tumor ▁Response▁", "▁Committe e▁on", "mon▁T oxicity▁", "▁antibodies ▁to", "▁evidence▁of ▁disease▁progression", "PT H", "hist ology", "kelet al▁surv", "e▁sh ould", "at▁a ▁minimum", "received▁ prior", "omega-3 ▁fatty▁acid▁", "▁diarrhea ▁(", 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"\n\nComplete▁Response▁(CR ):", "rate▁for▁solution▁for ▁infusion", "ERMINA TION▁OF", "▁of▁63▁Finalization▁date:▁June▁19▁2001,▁Incorporating▁amendment▁3▁–▁dated▁23▁May ,▁200", "\n\nQu ite▁a▁bit", "articulate▁ matter", "arget▁lesions▁should▁be▁select ed▁on▁the▁basis▁of", "epher d▁", "elegation▁of▁Author ity▁Form", "etoc onazol", "\n\nA▁little▁b it", "▁the▁poss ibility▁of", "▁was▁removed▁from▁the▁ regimen", ",▁Cold itz▁GA", ",▁Arb uck", "Proof▁of ▁Receipt", "atchful ▁wait", "censored▁using▁the▁ last", "▁Followed▁by▁M aintenance▁", "▁measurable▁lesions▁ up▁to▁a▁maximum", "▁AND▁REPLAC EMENT▁OF▁S", "MOVAL ▁AND▁REPLACEMENT▁OF▁S", "MINISTRATIVE▁AND▁L EGAL▁OBLIGATIONS", "MOVAL▁AND▁REPLACEMENT▁OF▁S UBJECTS", "% \n\n0", "( except", ") ▁after", ") ,\n\n", ") ▁within", ") ,▁and▁the▁", ", 4", ", 8", ", ▁any", "- 16", "- 65", "/ kg", "2 -sided▁", "3 ▁d", "4 .", "4 .0", "6 ▁cycles▁of", "7 .1", ": ▁•", "; ▁", "; ▁if", "A CR", "A gent", "C 225", "C ockcroft▁and▁Gault", "D B", "D M", "E K", "E ,▁S", "E RIO", "E astern▁Cooperative▁Oncology▁Group", "E ORTC▁QLQ-C30", "F unctional▁Assessment▁of▁Cancer▁Therapy▁", "F unctional▁Assessment▁of▁Cancer▁Therapy", "G ill", "H NC", "I mClone▁", "I ▁am", "K M", "L ong", "N ▁A\n\nF▁O", "P ower", "T R", "V ITAL", "Y Y", "a uc", "b ronch", "c ode▁", "c ovari", "c apecitabin", "c ounter", "d ated▁in", "d arbepoetin▁alfa", "d ays▁", "e av", "f ast", "f avorable▁", "g et", "m ount", "n y▁", "n atur", "o oxygen", "p alliative▁", "p ase-", "p ublic", "r urit", "s pecimen", "u it", "u fficient", "v oid", "w t", "w y", "w eb", "w ash", "w ould", "y ;", "y g", "y ▁are▁", "“ other", "▁ ................", "▁ et", "▁ e▁v", "▁ ®\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁Panitumumab▁Protocol▁Number:▁20050251▁Date:▁10▁October▁2006\n\nPage▁", "▁ outsid", "e▁ cell", "in ski", "▁t ype▁", "at ed▁based▁on", "\n\n cancer", "\n\n review", "\n\n analys", "\n\n subjects▁", "en berg", "er ated▁lung", "or ▁leg", "or adic", "s▁ 5", "s▁ is", "s▁ you", "re ed", "y▁ with▁the▁", "ion ucl", "it ▁is", "it ating", "▁the▁ Sponsor", "▁the▁ original", "▁the▁ IEC/IRB", "an -", ",▁ first", ",▁ provid", ",▁ may▁be▁", ",▁ Ad", ",▁ standard▁", ",▁ platelet", "▁an ▁individual", "▁an ▁abnormal▁", ".▁ Y", ".▁ 14", ".▁ ECOG", "ar -", "ed ▁tumour", "▁p rim", "▁p anel", "▁p ump", "▁p ellet]", "▁c op", "▁c ert", "▁c ynomolgus▁mon", "▁b e:", "es id", "es cent", "et on", "et ▁forth", "▁to ▁another", "▁to gether▁with", "is ▁a▁m", "is olon", "▁s ex", "▁s econdary", "▁s cientific", "▁s afety,▁", "as ed▁", "as ian", "▁of fic", "▁of ▁two", "▁of ▁previous▁dos", "ou ill", "▁w arrant", "▁m and", "▁m ild", "▁m CRPC", "▁and▁ A", "▁and▁ clinical▁", "▁and▁ has▁been", "▁and▁ final", "ect ed▁", ".\n\n 18", ".\n\n 28", "ill i", "is▁ responsible▁for", "▁A T", "iv e,▁", "oc rine▁", "▁1 ▁month", "▁C al", "▁C olon", "os cl", "os is▁or", "est ▁X-ra", "es▁ must", "▁P ublication", "pro xim", "pro gres", "▁( 7", "▁( excluding", "em an", "▁2 nd▁", "if f", "▁I HC", "ot o", "ag u", "ag ic", "▁D J", "▁D ATA", "▁l ot", "▁l ost", "▁l oper", "▁E R", "▁f all", "▁f ield", "am pt", "am ong", "ver ifi", "ch alleng", "▁or ▁breast", "▁or ▁rect", "▁or ▁drug▁delivery▁system", "e▁t ermin", "ys elf", "form ation▁of", "\n\nP rinted▁copy▁is▁not▁official▁record", "iz ed▁s", "ex ternal▁", "ec ret", "ist ribut", "per -", "▁and ▁abdomen", "▁as certain", "▁as ▁appropriate", "▁pro gres", "all ing", "▁T ranslational▁Research", "▁ad v", "▁ar is", "▁R el", "▁R NA", "▁R efer", "ed▁in ▁this▁document", "min eral", "In d", "In dependent", "\n\nS election", "▁that ▁particular", "▁al coh", "e▁s afety", "e▁s ee▁Section", "e▁th e▁sampl", "▁0 .2", "▁3 ▁days)", "▁con ven", "▁of▁the▁ drug", "cont ext", "▁F WB", ".▁A c", ".▁A s", ".▁A ▁subject", ".▁The▁ purpose▁of", "▁as▁ it", "▁g u", "▁g lobal", "hould▁ not", "200 5;", "▁on ▁Days▁", "▁v entricular", "▁v olunteer", "▁L ead▁", ".3 5", "s,▁ but", "▁ther efor", "▁st abil", "▁ch osen", "▁ch emoradi", "▁will ingness▁to", "follow ed▁by▁a", "ing▁the▁ t", "▁5 9", "▁5 .7", "will ▁occur", "from ▁the▁study▁", "▁H NC", "▁H &E", "and▁ m", "▁subject ▁with", "▁the▁p ost", "▁the▁p aclitaxel", "▁the▁p regnancy▁", "▁the▁p ackage▁insert", ")\n\n 2", ")\n\n [", "▁at \n\n", "▁at ▁the▁tim", "▁at ▁the▁first", "▁at ▁the▁time▁of▁the▁", "s▁( longest▁diameter", "▁study▁ will▁be▁", "ident ical", "s▁in ter", "s.▁ F", "s.▁ R", "s.▁ T", "▁week s▁and▁", "cons isting", "ell ing", "ation▁of ▁data", "▁patient s▁that", "▁the▁d et", "report ed▁by▁", "report ing▁of", "e▁the▁ Efficacy▁of", ".▁P ostdiscontinuation", "\n\nE fficacy▁Analysis▁Set", "▁In terim", "▁In dividual▁", "s\n\n H", "s\n\n of", ".▁Th e▁tim", "on- study", "▁may▁ requir", "▁dos e.\n\n", "pres s▁", "(cid: 11", "may▁ not", "e▁v itamin▁D", "ser tion", "▁analysis▁ data▁cut-off", ".▁In ▁the▁case▁of", ".▁E stim", ".▁E rlotinib", "record ed.\n\n", ",▁and ▁to", "11 3", "AL U", ".▁T issu", "ed▁with in▁the▁", "’s▁ b", "▁x ▁upper", "20 5-", ",▁or ▁m", "▁disease▁ assessment", "investigator ▁will", "▁9 2", "▁9 .4.1", "▁8 5", "▁8 5▁mg/m2", "e▁( or", "first -lin", "\n\nProduct: ▁darbepoetin▁alfa▁Protocol▁Number:▁20010145▁–▁Amendment▁2▁Date:▁16▁July▁2004\n\nPage▁", "\n\nN A*", "pre medic", "every▁ 12▁week", ").\n\n 10", "................................................................................ ...▁", "▁form ulation", "bas is▁for", "▁the\n\n IEC/IRB", "▁pre dominantly▁s", "ed▁as▁ follows:", "ass ification", "des pite▁", "▁a▁s creening", "14 -", "\n\nT able▁of▁Content", "▁the▁patient ▁must▁be▁", "respons es▁", "respons ibilities▁", ".▁D isease▁", "complet ed▁at", "▁W IT", "\n\n4 .9", ".▁F orm", "▁cons umption", "data ,▁", "I- L", ".\n\nP lease▁", "e▁b ecom", "13 ]", "\n\nI mmun", ",▁S afety▁", "▁panitumumab ▁or", "yst olic", "lind ing", "LC SS", "s▁or ▁s", "performed▁ using▁the▁", "equ ential", "▁death s▁", "ures ,▁", "▁30 ▁mg", "▁evalu ation▁of", "▁sampl e,▁", "ativ e▁treatment", ".▁R eg", ".▁R efer▁to▁Section", "you ▁will▁be▁asked▁to", "▁cell s▁in", "▁complet ion▁of", "\n\nH emoglobin", "NA **", "ed.\n\n 5", "ed.\n\n 9", ",▁P at", "St andard▁", "\n\n\n\n If", "▁CT X", "disease▁ (", "▁mod ul", "ed\n\n for", "▁analysis ▁and▁", "▁continu ous▁infusion", "▁occur s▁prior▁to", "dis position", "................................................ ..", "16 9", ".▁H y", ".▁H ar", ".2.1 .2", "▁must ▁ensure▁that", "observ ed▁at", "▁rel eas", "1- 3", "▁(A UC", "\n\nIn t", ",▁b reast", "risk s▁associated▁with", "\n\nB one▁", "\n\nB efor", "▁this ▁tim", "when ▁the▁", "▁advanc ed,▁", "▁advanc ed▁s", "▁advanc ed▁breast▁cancer", "blind ing", "▁chang e▁", ".▁J ▁Natl▁Cancer▁Inst", "▁effect ▁of", "........................................................................ .......▁", "well -being", "▁int ensity▁", "must ▁sign", "▁a▁c aus", "▁K :", ".▁I m", "ram p", "start ▁of▁treatment", "▁investigational▁product ▁will▁be▁", "▁has▁been ▁reported▁in", "\n\nL ong", "\n\nL aboratory", ",▁et▁al .▁Cetuximab", "ea u", "determin ed▁from", "determin ed▁that", "▁trans port", "s▁at ▁least", "mCl one", "identifi ed▁as▁target▁lesion", "Com pli", "\n\n5 .3", "count ry", "\n\ns urvival", "▁14 ▁days▁prior▁to▁randomization", "prov en", "▁ver ify", "43 1", ",▁L ee▁J", "\n\nAppendix ▁E", "\n\nAppendix ▁G", "\n\nAppendix ▁XIV▁Page▁", "▁under going", "▁the▁event ▁of", "caus ality", "▁Q oL", "▁assign ed▁treatment", "▁KRAS ▁mutation", "\n\nO xaliplatin", "▁between ▁1▁and▁", "▁pain ▁control", "TA ▁visit", "▁Adverse▁Event s", "▁Treatment ▁Group", "att ach", "▁long -term▁follow-up", "▁observ ed", "▁sp oradic", "ECOG ▁PS", "▁advanced▁ gastric▁cancer", "▁when ▁the▁", "▁pemetrex ed▁infusion", "70 ▁and▁", ".▁L aboratory▁", "withdraw ▁from", "mor e▁sever", "recommend ed", "▁accept abl", "ed▁( eg,▁", "urger y▁", "aw el▁J", "monitor ed▁for", ",▁199 8", "▁No .▁", "▁meet ing▁the▁", "▁of▁126 \n\n", "▁during▁the▁ treatment▁phas", "▁subsequent ly▁", "serum ▁creatinine▁", "mission ▁Form", "ed▁m easurable▁", ".▁199 7;", "has▁been ▁observed▁in", "oper able▁", "%) ▁patient", "▁Subject ▁incidence▁of", "e▁tumor ▁assessment", "opt im", "▁person al▁", "\n\nV EGF", "▁the▁f ull", "cas es▁", "........................................ ..", "protein ▁expression", "▁En rollment", "ed, ▁all", "inf us", "oler ated▁", "▁only▁ if", "▁Janu ary▁", "▁typ ically▁", "red▁ blood▁cell", "compar e▁", "remain der", "▁objective▁ response▁rat", "▁does▁not ▁meet", "▁individual ▁patient", "▁cediranib ▁in▁combination▁with▁FOLFOX", "e▁the▁s am", "de hydration", "lat ter", "▁4▁week s,▁", "▁en vironment", "▁NC I-", "reported▁ lesion", "control ▁group", "requir ing▁", "ually▁ for", "ed▁according▁to ▁local", "▁provide▁ an", "▁k ey▁", "measured▁ by▁the▁", "▁the▁subject’s▁ clinical▁", "calculated▁ from", "LD ▁of▁target▁lesion", "g/m l", "▁the▁primary ▁analysis▁of", "s,▁or ▁other", "outlin ed▁in", "mean ingful", "▁qual ify", "ert iary▁", "▁Follow ing", ".▁Subject s▁with", "▁serious▁adverse▁event ▁information", "ed▁by▁a erated▁lung", "combination ▁with", ".▁Ther eafter", "yndrom e▁(", "▁discus s", "\n\ni \n\n", "........................ ....", "▁minutes▁ on▁Day▁1", "escal ated▁to", "’s ▁assessment", "▁of▁119 \n\n", "valid ated▁", "Test ing", "▁investig ative▁sit", "▁ask ▁question", "\n\nx▁x▁x \n\nx▁x▁x", "▁Monitoring ▁Committee", "ackgroun d", "compli ant", "randomis ed▁to", "volum e▁", ",▁v on▁P", "dent ification", "earli est", "▁bon e▁turnover▁marker", "co ordinating▁investigator", "▁................................................................ ......", "Gen eral▁", "astric ▁Cancer", "e▁dose▁ by▁", "▁patients▁( pts)▁with", "s.▁Th ese▁", "▁Denosumab▁Protocol▁Number:▁20050136▁Date:▁30 ▁April▁2008", "Investigator’s▁ Agreement", "vascular ▁endothelial▁growth▁factor", "▁Pl anned▁Methods▁of", "\n\nPrimary▁ Objectiv", "▁Health care▁", "▁normal▁ limit", "stitutional▁Review▁Bo ard▁", "e▁during▁the▁ study", "s.▁If ▁the▁", "ohn ’s▁", "▁of▁98 \n\n", "likely ▁to▁be▁", "▁the▁inter vention", "ordin ator", "\n\nAmgen▁Thousand▁Oaks \n\nConfidential\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040135▁Date:▁14▁November▁2006\n\nPage▁", "▁liver ▁metastases▁", "vari able▁", "▁to▁a void▁", "sufficient ly▁", "drawn ▁from", "▁lymph ocyt", "\n\nComplet ely▁disabled.▁Cannot", "▁(d epending▁on", "▁malignanc y▁", "Man ual", ",▁ch ills,▁", "▁Monitoring▁Committe e▁(DMC", "icro ar", "elv ic", "elv is▁", "resect able,▁", "▁decrease▁in ▁the▁sum▁of▁the▁", "Ass ociation", ".▁With in", "▁continuous▁ daily▁", "▁these▁s ide▁effect", "▁the▁information ▁provid", "\n\nDiscontinu ation▁of", "▁expect ed▁to", "elan i", "Analys es▁", "boemb olism", "▁regular ▁interval", "\n\n75% \n\n75%", "▁micro ar", "▁ref us", "standard▁of ▁care", "▁three▁ week", "▁Procedures▁for ▁All", "▁95%▁CI :▁0", "▁birth ▁control", "▁x-ra y", "anticip ated▁", "end▁ date▁", "olunt ary▁", "▁2.5 ▁mg/kg", "ackaging ▁and▁", ";▁( 3)", "could▁ be▁", "bod y▁system", "s▁(or ▁sites▁of▁diseas", "▁minim ize▁the▁", "\n\n2\n\n2 \n\n2\n\n2", "\n\n(cid:13 1)", "e▁sub scale▁scor", "contracept ive▁", "▁intern al", "color ation", "▁explor e▁", "▁explor e▁the▁", ".▁Gen eral▁", "▁Backgroun d▁and▁Significance:", "ixed▁ effect", "e▁sign ificant", "e▁inter vention", "emper ature", "oss ella▁F", "▁cho ic", "ated▁b enefit", "],▁ [", "▁CBC ,▁differential", "intend ed▁to", "over▁the▁ 36-month▁evaluation▁period", "\n\nRec ording▁of", "round ed▁by▁aerated▁lung", "▁2-sided▁ 95%▁confidence▁interval", "Schedule▁( Attachment", "▁Biomarker ▁Development", "▁commun ication", "▁carry▁on ▁any▁s", "Oral▁Rectal▁ Oral▁Rectal▁", "▁Aci d▁", "▁express ing", "ed▁by▁Lilly :", "▁experiment al", ".▁Specific ally,▁", "▁contracept ive▁", ",▁et▁al.▁Phase▁ II", "▁hormone- resistant▁prostate▁cancer", "left ▁to", ",▁blood▁ pressure,▁", "▁the▁baselin e▁sum", "▁(W estern", "Journal ▁of▁", "▁SY NOPSIS", "s▁that▁can▁be▁ accurately▁measured▁in", ".\n\nSUBJECT ▁ENROLLMENT", "strongly▁ encouraged▁to", "e▁disease▁ assessment", ",▁Man egold▁C", "▁time▁from ▁randomization", "▁ruler ▁to▁estim", "scan n", "▁adequ ately", "complete▁or ▁partial▁response▁", "▁actual ▁body▁weight", "followed▁for▁survival▁ for", "doubl et", "▁μ g", "empor ary▁", "▁every▁4▁week s▁schedul", "no▁less▁than ▁4▁weeks▁after", "▁Stage▁III B", "altz ▁LB", "uper ficial▁", "\n\nEGF r", "measurements▁and▁ variables", "▁Lilly▁or▁its▁designee▁ via", ",▁who ▁will", "obil ity", "other▁than▁the▁ evaluation▁or", "▁Previously▁ Un", "EDTA ▁blood▁[plasma▁and▁cell", "▁>99.9 ▁>99.9", "stitutional▁Review▁Board▁( IRB)", "▁patients▁per ▁arm", "orrection s▁to", "▁sourc e▁data", "▁Darbepoetin▁alfa ▁Protocol▁Number:▁20010145", "▁advert ising", "▁resid ual", "▁curative▁ intent", "unningham ▁D", "▁proportional▁hazard s▁model", "\n\nResult s▁in", "▁SG ,▁Eisenhauer", "▁prem atur", "embry onic", "▁120▁mg ▁SC", "▁head▁and▁neck ▁cancer", "s▁Ad minister", "▁you▁are▁a ▁woman", "able▁Disease▁ (SD):", "▁hybrid ization", "▁imagin able▁", "re-s creen", "▁Recon ciliation", "\n\n5\n\n6\n\n7 \n\n8\n\n9", "e,▁ALT,▁AST ,▁calcium", "including▁a ▁ruler▁to▁estim", ".\n\nEX PERIMENTAL▁PLAN", "financ ial", "▁has▁returned▁to▁baselin e,▁then", "▁conduct▁of▁the▁ clinical▁investigation", "▁mm▁with▁conventional▁techniqu es▁or", "▁will▁compensate▁you▁if▁this▁h appens", "▁ambulatory▁and ▁able▁to▁carry▁out", "▁6▁1 ▁G▁M", "asse▁P ,▁Arbuck", "▁INFORM ATION", "atzemeier ▁U", "-and- subsequent", "▁and▁the▁same▁techniqu e▁should▁be▁used▁to", ",▁PAX gen", "▁work▁of▁a▁light▁or▁sedentary▁n ature,▁", "heumatoid ▁arthrit", "censored▁using▁the▁last ▁available▁", "auc asian", "or▁leg al▁partner", ",▁von▁P awel▁J", "▁SG,▁Eisenhauer ▁EA", "including▁a▁ruler▁to▁estim ate▁th", "▁6▁1▁G▁M ▁A", "asse▁P,▁Arbuck ▁SG,▁Eisenhauer▁EA", "( as▁", "( IHC", ") /", ") ▁In", ") ▁-", ") ▁was", ", ▁the▁sponsor", ", ▁treatment▁with", "- re", "- 99", "- by-", ". E", "/ 0", "/ PR", "/ vomiting", "/ exclusion▁criteria", "0 .9", "1 ▁year", "3 00", "8 5-", "8 5%", "8 2)", ": ▁An", "; ▁s", "> 2", "A mendment", "C o", "C hemistry▁", "C ollection", "D iscontinu", "E I", "E TA", "E pidermal▁", "H ochberg", "H ARM", "I m", "L ,▁C", "M ,▁C", "N -", "O bl", "R ational", "T X", "a ud", "b ound▁", "b etter", "d evi", "e \n\nAn", "e agu", "f ram", "f oot", "g ulin", "i ou", "i oc", "i eth", "k ▁r", "l though", "l iving", "l earn", "m l", "m y▁", "n es", "n ect", "n ▁=", "p eptid", "s ”", "s ▁according▁to", "s creen", "s urgical▁", "s ophag", "u z", "v inc", "v endor", "w k", "w orldwid", "y ing", "” ▁(", "▁ \"", "▁ ×", "▁ formation", "▁ open-label▁Casodex", "e▁ you", "e▁ into", "e▁ would▁", "in e,", "▁t ▁s▁", "on d", "on al▁", "on ▁D", "\n\n >", "\n\n at", "\n\n as", "\n\n blood▁", "\n\n bevacizumab", "\n\n yes▁", "▁a ▁trial", "er a", "er ▁S", "or st", "or ubicin", "s▁ /", "s▁ following", "s▁ versus▁", "s▁ such", "s▁ resulting▁from", "re vascularization", "al ive▁", "ent r", "it e\n\n", ",▁ may▁", ",▁ dos", ",▁ only▁", ",▁ followed▁by▁", ",▁ including▁the▁", "ed▁ “", "ed▁ following", "▁an ▁appropriate▁", "▁an ▁additional", ".▁ [", ".▁ c", ".▁ 12", ".▁ 25", ".▁ 30", ".▁ 22", "ed ?", "ed ,\n\n", "ed ▁appropriate▁", "▁p ast", "▁p olicy▁", "▁c o-", "▁c apt", "▁c apture", "ing ▁treatment", "es .▁C", "for d", "▁to ▁collect", "▁to ▁participate▁in▁the▁", "is ,▁and▁", "is ▁associated▁with", "▁of ▁cycle▁", "▁d estroy", "▁w eb", "▁w ould", "▁m anufact", "▁and▁ h", "▁and▁ study▁", "▁and▁ irinotecan", "▁and▁ last", "▁and▁ results▁of", "▁and▁ check", "▁and▁ platelet▁count", ".\n\n c", ".\n\n (cid:", ".\n\n Un", ".\n\n 26", "al▁ (", "al▁ S", "al▁ f", "al▁ vitamin▁D", "al▁ 5-fluorouracil", "el and▁", "el son", "▁A G", "▁A MGEN", "▁A fter", "im put", "ig ment", "id d", "id imension", "▁1 5-", "▁1 80", "▁1 ▁or▁2", "▁C K", "▁C ur", "▁C riterion", "ac etic", "pro mpt", "pro portional▁hazard", "▁( <", "▁( JM", "▁( EGFr", "▁( VEGF", "▁( Visit", "▁( includes", "▁( wt", "em otion", "us iness▁", "ul ated▁", "con ven", "con omic", "con stant", "▁S TA", "▁S 130", "▁S teering", "▁I ▁have▁", "▁re combinant", "ag ain", "▁D ate▁of", "▁D uration▁of", "▁D ▁E▁T▁N▁I▁R▁P\n\nA", "▁D elegation▁of▁Authority▁Form", "cl -", "ri x", "▁h is▁", "▁h eparin", "▁E astern▁Cooperative▁Oncology▁Group▁(ECOG)", "ject ▁the▁", "▁or ▁SD", "▁or ▁less", "e▁t oday", "\n\nP ost", "\n\nP AGE", "ec ision", "\n\nA pproximately▁", "study▁ duration", "▁pro ce", "▁pro pert", "▁ad jacent", "ast inal", "▁for ▁other", "▁for ▁Arm▁A", "▁for ▁injection", "▁R ,▁B", "e\n\n of", "rom et", "▁treatment ▁should▁be▁", "enc ounter", ".1 5", ".1 8", "▁with ▁treatment▁group", "▁with holding", "ed▁b one▁", "s▁of ▁the▁data", "In f", "▁that ▁it", "▁200 20408▁Amendment▁4", "▁is▁ obtain", "▁of▁ study-related▁", "▁al ert", "e▁s election", "▁M D", "▁M I", "▁M aster", "▁0 .25", "event -", "event ▁analysis", "▁of▁the▁ treatment", "wh os", "▁com menc", "▁F A", "▁F F", ".▁A b", "▁as▁ ≥", "▁g astrointestinal", "▁g efitinib", "▁on ward", ",▁and▁ S", "rad ionucl", "▁L etter", "ly▁ diagnos", ".3 9", "▁this▁ substudy", "▁st ay▁", "\n\nC apable▁of▁only▁limited▁s", "▁will ▁help", "e▁in terim", "e▁in fection", "e▁in terval", "▁5 8", "▁5 25", "▁5 .5.1", "will ▁also", "will ing▁or", "▁6 -week", "▁H RPC", "▁patients▁ in▁the▁", ")\n\n and▁", "▁at ▁any▁", "▁at ▁the▁end▁of", "s▁( such▁as▁", "▁the▁in struction", "▁ac com", "▁ac company", "▁study▁ conduct", "\n\n1 .2", "▁mg ▁AMG▁162", "ire gulin", "ens ure▁that", "▁the▁t yp", "▁after ▁2", "ed▁on ▁a", "19 89", "EC ORD", ".▁S h", ".▁S ome▁", ".0 ▁mL", ".0 ▁g/dL", "▁patient ▁population", "▁un stain", "▁e qual", "▁J ournal", "▁tim e-to-event", "▁from ▁baseline▁", "▁from ▁the▁treatment", "s\n\n must▁be▁", "ed▁by▁ subject", "ax is", "▁Protocol ▁Number", ".▁Th e", "et▁al ,▁200", "▁tumor ▁for", "ON E", "▁dos age▁", "roduct ion▁of", "ost on", "CT /MRI", "es▁of ▁America", "may▁ have▁", "▁adverse▁event s▁will▁be▁", "mon otherapy", "pect romet", "▁10 .5", ".6 8", ".▁In t", "▁assessment ▁and▁", "▁assessment ▁is▁", "▁sign ificance▁", "▁sign s▁the▁", "peri pheral", "20 ]", ",▁or ▁an", "progression ▁fre", "patient s▁are▁", "▁9 8", "▁9 .4", "e▁( NCI", "s▁s elect", "s▁s pecifi", "▁each ▁treatment▁group", "pre pared", "every▁ effort▁should▁be▁made▁to", "every▁ 8▁weeks▁±▁1▁week", ".7 7", "\n\n2 6th", "y▁of ▁the▁", "▁should▁be▁ follow", "▁should▁be▁ exerc", "roll ed▁", "▁the▁investigator (s)", "▁the▁investigator 's▁", "▁the\n\n primary▁", "ed▁as▁ part▁of▁the▁", "easure s▁", "protocol -specifi", "ating ▁that", "ron ically▁", "ed,▁ with", "respons ibility", "respons ible▁", "\n\nY es▁or▁No", "▁addition ▁to▁the▁", "▁The▁ following", "▁the▁l ower", "▁dose▁ and▁", "▁dose▁ adjustment", "coll eagu", "KRAS ▁status", ".\n\nP emetrexed▁H3E-MC-JMHR(b)▁Confidential\n\nProtocol▁Amendment\n\nPage▁", ".\n\nP OTENTIAL", "e▁b enefit", "s▁to ▁follow-up", "13 )(cid:", "▁panitumumab ▁in", "oth enberg", "s▁or ▁term", "▁was▁ observed▁in", "▁Clinical▁ Study▁", "▁Version ▁4.0", "ung al", "▁death s▁have▁occurred", "▁30 -day▁", "▁evalu ate▁t", "provid er", "provid ed▁with", "sign ing▁this▁", "using ▁the▁same▁", "▁sampl ing", "ox orubicin", "until ▁disease▁progression▁or", "▁mg/m2 /day▁", "▁the▁subject ’s\n\n", "inter est", "▁complet ely▁", "▁approximately▁ 10", "▁approximately▁ 745", "▁particip ate", "▁discontinu ation▁of▁the▁", ",▁P FS", ",▁P lacebo", "valu es▁", "\n\n\n\n \n\n", "▁et▁al ▁200", "▁et▁al ▁2007", "▁et▁al .▁19", "▁analysis ,▁", "▁continu e▁in", "▁continu e▁to▁receive▁", "ed▁s urvival", "collect ed▁to", "▁= ▁area", "▁response▁ rate▁of", "dose▁ (", "16 0", "▁should▁ only▁be▁", "▁these▁ studies", "▁these▁ agent", ",▁M at", ",▁M oor", "RO QOL", ".▁H arris▁WS", "▁must ▁submit", ",▁C D", "observ ed▁in▁the▁", "▁(A BI-007", "▁result ed▁in", "ation▁of▁ study▁drug", "man ager", "review ▁of▁the▁", "s, ▁as▁", "s, ▁tumor▁cells▁and▁the▁proposed▁mechanism▁of▁action", "▁19 76", "e▁m easure", "▁chemotherapy▁ with", "able▁to ▁Evalu", ".▁This▁ will▁be▁", "clinical ▁benefit", "ull er", "hib its▁", "rati os", "▁this ▁amended▁protocol", "▁PFS ▁in", "ed▁a mong", "▁Arm ▁G", "▁12 ▁week", "studies▁ have▁", "rat um", ".\n\nC h", "clusion ▁Criterion", "ech t", "OLF OX-", "must ▁not▁be▁", ".▁For ▁the▁", "Clinical▁Study▁ Report", "▁agent s,▁", "▁agent (s)", "▁• ▁S", "FA S", "▁increas ed▁in", "▁this▁study▁ protocol", "s▁on ly", "▁AE s▁and▁SAE", ",▁et▁al :", ",▁et▁al .▁S", "io ▁n", "s▁and ▁their", "▁anti- AMG▁162", "\n\n5 .\n\nSUBJECT▁ENROLLMENT", "Con comitant▁medication", "▁ver tebra", "cer ning", "▁the▁sam e▁m", "IC H)", "indic ate▁that", "21 ]", "▁Dec reas", "IRB ▁or▁IEC", "▁toxicity▁ grade▁", "evid ence▁", "▁for▁the▁ following", "\n\n9 .4", "▁of▁a ▁new", ",▁in ▁which", "▁agre e▁that", "person ally▁", "only▁ for", "▁overall ▁survival▁", "Treatment ▁of", "EGFR -", "100 ▁mg/m2", "▁medical▁ emerg", "▁an▁ option", ".▁L ong", "e/ Cisplatin", "her ein", "y▁( CT", "2- 7", "\n\nth roughout", "▁record ed▁", "-fre e▁disease▁assessment", ",▁d epending▁on", "▁Med icin", "▁100 )", "▁procedure s▁for", "▁have▁been ▁report", "FACT- L", "vestigational ▁drug", "▁are▁not ▁confirmed", "pers ed", "▁design ed▁to", "▁≥ 2", ".\n\n3 .1", "e▁P 450", "ren al▁function", "3- year", "Ph arm", "▁If ▁you", "used▁in vestigational▁product", "cas es,▁", "/d ay", "▁skin ▁reaction", "▁Ex t", "non e)", "▁appropri ate,▁", "▁PR ▁or▁CR", "▁the▁trial ▁are▁", "ourn al▁", "▁ident ical", "it▁is▁ estimated▁that", "controll ed▁trial", "lik ely▁", "\n\nd enosumab", ".\n\nB evacizumab", "chest ▁CT", "FOLFOX 4", "▁(S GOT", "▁alon e", ",▁all ▁subjects▁", "▁a▁l egally▁acceptable▁", "increas e▁the▁", "linded▁ Treatment", "▁experienc es▁a", "▁before▁ study▁", "▁before▁ randomization", "▁local▁ institutional▁practic", "measurable▁ diseas", "es▁that ▁are▁", "▁grade▁ 2", "▁days▁ following", "s▁a mong", "\n\nNo \n\nPR", "health ▁status", "▁known ▁to▁have▁", "old berg", "▁For ▁all", "▁(P SA)", ".▁5 8", ".▁5 .7", "medical ▁car", "▁of▁0 .025", "\n\nW eek", "establish ed▁tumor", ".\n\n8 .2", ".\n\n8 .3", "assign ed▁to", "▁availabl e.\n\n", "-in duced", "▁full ▁consent", "persensitiv ity▁to", "ummary▁ statistic", "astro enter", "▁(cid: 116)", "with▁the▁ exception▁of", "atory▁ Obl", ".▁Ex pos", "delay ed▁", "expos ure▁", "was ▁also", "▁of▁127 \n\n", "1.5 ▁x▁ULN", "s▁may▁ occur", "▁use▁ adequate▁", "LT ▁<", "▁activity▁ but", "e▁C asodex", "▁compared▁with ▁docetaxel", "\n\nCon t", "before▁ each", "consistent ▁with▁the▁", "▁do▁not ▁have▁", ".▁Addition ally", "▁los s,▁", "-related▁to xicity", "Safety▁ Follow-Up", "▁agree▁to ▁ensure▁that", "Objectiv es:", "▁anti androgen", "may ▁also▁be▁", "▁minutes▁ prior▁to", "escal ation", "▁anticancer ▁therapy▁", "▁2▁year s▁after", "prior▁to▁the▁ first▁dose▁of", "▁fract ures", "\n\nNot ▁at▁all", "▁or▁s ponsor", "▁small ▁lesion", "▁center s:", "TIN AL", "colon y▁stimulating▁factor", "colon ▁or▁rect", "▁5-fluorouracil /leucovorin", ".▁St at", "▁Ant i-", "complete▁ respons", "complete▁ response▁", "Ch aracter", "s.▁B iometrics▁", "dent ity▁of▁investigational▁product", "▁participating ▁in▁the▁study", "▁Engl and▁", "initi ally▁", "local▁ regulatory▁requirement", "°C ▁(", "▁Non- metastatic", "▁a▁b est▁response▁of", "how ▁good▁", "▁Sign ature▁", "▁Sign atory▁Obl", "Investigator’s▁ Brochure▁", "\n\nPrimary▁ Endpoint", "▁measurable▁ disease▁", "begin ning", "al▁s equence▁", "▁component s▁of", "▁abov e▁", "▁major ▁body▁system", "ed▁M etastatic▁Colorectal▁Cancer", "▁Primary▁ Endpoint", "▁Study ▁to", "predict ive▁", "Reg ulatory▁A", "▁Serious▁Adverse▁Event ▁Reporting", "e\n\nC onfidential\n\nPage▁", "▁able▁to ▁carry▁on", "leg ibl", "▁tr uly▁", "vertebral▁ fracture▁", "angu age", ",▁con fined▁to▁bed▁or▁chair", "following▁the▁ last▁dose▁of", "▁documented▁ disease▁progression", "▁mg/dL ;", "every▁6▁week s,▁", "▁original ▁source▁document", "▁treatment▁effect ▁on", "examin ing", "ate▁( or", "occurred▁ in", "▁curv es▁will▁be▁", "▁sequ ential", "▁bisphosphon ates", "▁alpha ▁level", "predn ison", "uroQol ▁Group", "▁recon struction", "▁pros pectively▁", "▁deriv ative▁", ",5 00", "idem iol", "decision ▁to", "▁match ing▁placebo", "use▁ only", "▁important ▁medical▁event", "purpos es", "keletal▁ related▁event", "▁Ep idemiol", "▁pemetrexed▁and▁ cisplatin", "▁objectiv es▁and▁", "▁related ness▁to", "ers us▁", "▁unit ▁errors▁(", ".2.1.1 .6", "utiliz ed▁for", ".\n\nST A", "iller ▁J", "▁Cons ider", "antibod ies", ".\n\nY▁T▁I▁D▁I▁L▁A▁V \n\nS▁T▁I", "30-day▁postdiscontinuation▁follow-up ▁visit", "eryth ema", "may▁occur ▁between▁1▁and▁", "described▁in▁the▁ protocol", ";▁( 2)", "vs▁ no", "-based▁chemotherapy ▁and▁bevacizumab", "▁objective▁progression -free▁disease▁assessment", "Ne uropath", "differ enc", ".\n\nS▁T▁I\n\nK▁C▁E▁H▁C \n\nE▁S▁A▁E▁L▁P", "▁dispens ing", "▁chemistry▁ panel", "regulatory▁author ities", "hemorrh age▁", "publication ▁or", "▁peopl e▁", "▁the▁sub group", "ost- Study▁", "▁10.6 .2.1", "metab ol", "color ▁photograph", "▁consult ation▁with▁the▁", "\n\nProtocol▁Attachment▁JM HD", "United▁Stat es▁of▁America", "▁anthracycl ine▁", "Reduction s▁for", "▁vis ual", "▁Backgroun d▁", "▁York ▁Heart▁Association", "▁carcin omas", "▁at▁least▁on e▁dimension", "▁head ach", "height ▁(", "▁mucos itis", "▁Investigator’s▁ Brochure", "(8 ):▁p.▁", "ed▁in▁the▁Study▁ Plan", "▁participation ▁in▁the▁study", "e▁size▁of ▁the▁lesion", "▁circumstanc es▁", "commer cial", "(mg /dL", "upd ates", ".\n\nY▁P▁O▁C \n\nD▁E▁T▁N▁I▁R▁P", "inorel bin", "▁150▁mg ▁once▁daily▁", "▁carcinoma▁of▁the▁ head▁and▁neck", "participation▁in▁the▁ clinical▁study", "Figure▁ S130", "appearance▁of▁all ▁target▁lesion", "langu age▁", "othelin ▁receptor", "▁measurements▁and▁ variables", "stability▁ limit", "▁Oncology▁ Group", "▁viol ation", "▁other▁lesion s▁(or▁sites▁of▁diseas", "Experienc e", "cagliotti ▁G", ".\n\nSUBJECT ▁ELIGIBILITY", ".▁Refer ences", "▁tempor al▁sequence▁", "▁signature▁ p", "index ▁scor", "▁previously▁untreat ed▁", "anadian ▁Cancer▁Societ", "▁a▁larg e▁", "▁inspect ing▁the▁", "-▁or▁nail -related▁toxicities", "▁thought ▁to▁be▁", "▁200401 35", "s▁suggest ive▁of", "▁Character istic", "echnical▁ Standard", "▁is▁any▁ untoward▁medical▁occurr", "ensive- stage▁", "dependent▁Ethics▁Committe e▁(IEC", "s▁treat ed▁at▁the▁", "unable▁to▁toler ate▁", "epatitis▁ B", "▁timely▁ manner", "▁phen otyp", "\n\nNumber ▁of", "Fract ure▁", "ed▁by▁clinic▁visit▁or▁telephone▁contact ▁approximately▁every▁6▁months▁for", ".▁Effect s▁of", ",▁Bon om", "aternal▁expos ure", "▁to▁d istinguish", "▁surviv al▁pro", "▁(AE )", "▁or▁your ▁legally▁acceptable▁representative▁", "▁must▁have▁a ▁negative▁", "▁differential▁ (neutrophils,▁", "▁ g", "ence▁or ▁absence▁of", "▁translational▁ research", "▁metastatic▁colorectal▁cancer▁(mCRC )", "ULATORY ▁OBLIGATIONS", "hort▁Form ▁(", "remit ies", "ological▁imaging ▁of▁the▁", "▁postmenopausal ▁women", "s▁will▁be▁calcul ated▁and▁", "▁health▁stat e▁today", "oftw are", "▁prolongation▁of▁existing ▁hospitalization", "▁a▁20% ▁increase▁in", "▁satisf action", "▁ENDPO INTS", "s▁with▁respect▁to ▁both", "▁transamin as", "▁has▁already▁ been", "compati bl", "▁mutant▁KRAS ▁tumor", "▁Supportive▁ C", "\n\nAm bulatory▁and▁capable▁of▁all▁s", "▁contribution s▁to", "ebrovascular ▁accident", ".▁(for ▁Japanese▁sites▁only", "rosatellite▁in stability", "Double- Blind", "Gleason ▁scor", "▁thor ough", "▁(longest▁diameter ▁to▁be▁", ".▁Totally▁con fined▁to▁bed▁or▁chair", "lymph▁node▁ is▁N", "▁Dosage,▁Administration ,▁and▁", ".▁Proceeding s▁of▁the▁", "at▁the▁end▁of▁treatment /withdrawal▁visit", "ytochrom e▁P450", "dre w", "▁of▁existing ▁non-target▁lesion", "s,▁S ubset", "▁stratified▁by▁the▁randomization ▁factor", "▁and▁cardiovascular ▁disease▁", "▁unable▁to▁carry▁out ▁any▁", "▁persistent▁or▁significant▁disability/inc apacity", "”▁and▁ “", "▁SI ZE", "▁BPI ▁scor", "▁Committee▁on ▁Cancer", "▁and▁Tim ing▁of", "ef▁Pain▁Inventory▁ –▁S", "arget▁lesions▁should▁be▁selected▁on▁the▁basis▁of ▁their▁size▁(", "Proof▁of▁Receipt ▁Form", "▁alcoh ol", "ALU ATIONS", "▁time▁from▁randomization ▁date▁to", "other▁than▁the▁evaluation▁or ▁conduct▁of▁the▁clinical▁investigation", "▁Darbepoetin▁alfa▁Protocol▁Number:▁20010145 ▁Date:▁16▁July▁2004\n\nPage▁", "including▁a▁ruler▁to▁estimate▁th e▁size▁of▁the▁lesion", "HARM AC", "willing▁or ▁unable▁to", "\n\n26th ▁April▁2005", "clusion▁Criterion ▁[", "colon▁or▁rect um", "how▁good▁ or▁b", "▁Signatory▁Obl ig", "may▁occur▁between▁1▁and▁ 9", "▁temporal▁sequence▁ from", "( 18", "( 2)", ") ▁as▁", ") ▁and/or", ") ▁plus▁", ") ▁have▁been", ", ▁temperature", "- th", "- drug", "- 25", "- na", "- approv", "/ no", "/ 100", "/ infusion", "0 -", "1 a", "1 50▁mg", "2 .", "2 ▁and▁", "3 )\n\n", "7 ▁September▁2007", ": 13", "; ▁in", "A D", "A p", "C hemistry", "C onfidential\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040138▁Date:▁19▁February▁2008\n\nPage▁", "E uroQ", "H ▁agonist", "I mClone▁LLC", "K ing", "K ,▁L", "K aplan", "L ab", "L ast", "L an-D", "M ARY", "N tx", "P Y", "T oxic", "T umour", "W omen", "[ RNA", "a ,▁", "a ult", "a eno", "b ecom", "b isphosphon", "c ision", "c ross", "c irculating", "d ep", "d ail", "d evic", "d efici", "f el", "f fusion", "h ospital▁or", "i )", "i ec", "i ary", "k ey▁", "l cer", "l isting", "m L", "m any▁", "m olecular", "m echanism▁of▁action", "n ia", "n ing▁of▁the▁", "o y▁", "o ▁S", "o ▁R", "o encephalopath", "o embryonic", "p end", "r ising", "s \n\nD", "s cientific", "s pecial", "s ▁approximately▁30", "t inent", "v in", "w ent", "y .", "y rimidine▁", "≤ ▁5▁x▁ULN", "▁ ................................................................................................", "▁ util", "▁ opinion", "▁ judgment", "▁ room▁temperature▁", "in h", "in hibitor", "▁t ext", "▁t rue▁", "at o", "at es▁in", "at ▁baseline▁", "at ▁Week", "on ▁subject", "on ▁day▁1", "\n\n <", "\n\n investigator", "\n\n was▁", "\n\n visit", "\n\n without", "en ough", "er lin", "er cent", "s▁ it", "s▁ ................................................................", "re ad▁", "re dient", "al ic", "al ter", "st age▁of", "st abiliz", "st omach", "y▁ [", "ent ry", "it ud", "▁the▁ physician", ",▁ us", ",▁ not", ",▁ so", ",▁ 14", ",▁ cer", ",▁ based▁on▁the▁", ",▁ changes▁in", "ed▁ drug", "ed▁ product", "▁an ▁additional▁", ".▁ ", ".▁ 35", "ed ▁the▁study", "ed ▁throughout", "▁p -valu", "▁p amidron", "▁p articulate▁matter", "▁c ap", "▁c ourse▁of", "▁c ovari", "ing ▁Group", "ing redient", "▁b urden", "▁b ullet", "es k", "es ,▁the▁", "es ▁to▁be▁", "es .▁B", "ation s,▁", "▁to ▁other", "▁to ▁be\n\n", "▁to ▁the▁date▁of", "▁to ▁assess▁the▁", "▁to ▁the▁date▁of▁death", "is ul", "▁s quamous▁", "▁s impl", "▁s ummary▁of", "▁s afety▁and▁efficacy▁", "▁s witch", "▁of ▁previous▁", "▁d egree▁of", "▁w ar", "▁w orld", "▁m it", "▁m ain", "▁m amm", "▁m easures", "▁m ortality▁", "▁m itoxantrone▁", "▁m sec", "▁and▁ g", "▁and▁ subject", "▁and▁ must▁be▁", "▁and▁ may▁be▁", "▁and▁ dis", "▁and▁ design", "▁and▁ blood▁sampl", "▁and▁ vitamin▁B12", ".\n\n 21", ".\n\n (cid:131)▁You", "ment ion", "ab solut", "▁A bstract", "▁A fric", "▁in ▁study▁", "▁in ducer", "res ist", "ig and▁", "▁C IMP", "▁C anada", "▁C XR", "ac ular", "ac cru", "es▁ P", "es▁ contain", "▁P CR", "pro duced", "▁( in", "▁( 17", "em bl", "▁2 :", "▁2 84", "us e▁vial", "ul um", "ul sky▁", "if ies", "▁S ymptom", "▁S tudies▁", "▁re cur", "▁re plac", "▁re fract", "▁re vis", "un likely▁to", "▁D ocetaxel", "▁D emographic", "ri ev", "▁h epatic", "▁E M", "▁E astern▁Cooperative▁Oncology▁Group", "▁f ood", "▁f atigu", "▁f olic▁acid", "ver ifying", "ch anc", "▁or ▁non-", "e▁t rial▁", "e▁t ime▁to", "ir reversibl", "qu ire▁", "ec ros", "end -of-", "▁n g/ml", "\n\nA s▁of▁22▁March▁2007", "study▁ protocol", "▁and ▁treatment", "▁and ▁these▁", "▁O c", "▁O per", "▁as ▁they▁", "▁as eptic", "up tion", "▁N e", "ef ram", "will▁be▁ based▁on", "com mittee", "▁for ▁vitamin▁D", "and ara", "▁R H", "▁R et", "e\n\n M", "e\n\n randomization", "rom ycin", "ed▁in vestigational▁product", "ed▁in ▁your▁medical▁record", "enc y▁and▁", "enc y▁s", "ed▁b as", "ed▁b lock", "In terim", "In stitut", "\n\nS econdary", "▁that 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ga", "▁In struction", "▁In dex", "oun c", "s\n\n 3", "s\n\n 6", "s\n\n and▁", "s\n\n Replace:", "evalu able▁for", "▁tumor ▁or", "▁tumor s,▁", "ON TIN", "▁month s", "effect ▁of▁treatment", "(cid: 116)", "may▁ includ", "▁adverse▁event s▁of", "amin ophen", "▁per tinent", "pec ify", "pec imens", "s) ,", "▁10 .2.3", ".6 1", "▁to▁the▁ Efficacy▁of", "▁analysis▁ in", ".▁In itial", ".▁In formed▁Consent", ".▁E valu", ".▁E Q-5D", "▁test s,▁", "▁test oster", "18 ]", "are sthes", ",▁and ▁all▁other", "11 1", "▁sign s", "▁sign ature", "40 %", "par ametric", ",▁or ▁a", "▁in▁the▁ D", "radi o", "e.\n\n 3", "e.\n\n 10", "patient -reported▁", "25 ▁mg/m2", "▁9 .2.1", "e▁( 1)", "s▁s et▁forth", "▁us e▁a", "\n\nN C", "▁data ▁cut-off", "▁trial ▁supplies", "y▁of ▁Sci", "bas is", "▁should▁be▁ administer", "▁should▁be▁ retain", "▁lesion s▁per▁organ", "\n\nR eport", "17 9", "NC Y", "▁the\n\n following", "▁pre val", "\n\nF OLFIRI", "On ly", ".▁D ocument", "s▁are▁ identifi", "▁dose▁ in", "complet ed▁in", ".\n\nA 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▁of▁the▁study", "▁person ▁who", "s; ▁and▁", "s; ▁however", "▁bi as▁", "▁randomized▁ patient", "/d ocetaxel", "▁informed▁consent ▁document", "open-label ,▁Phase▁3", "e▁sampl es▁will▁be▁", "pain ▁severity", "pain ▁interfer", "vitamin▁D ▁supplement", "▁PR ▁nor", "rin alysis▁", "▁marker s▁", "s,▁and ▁the▁", "s,▁and /or", "▁clinical▁trial s,▁", "\n\nd emonstr", "▁subjects▁who ▁develop", "skin ▁toxicity", "pharmac ological", "s▁includ ed▁", "▁minutes ▁apart", "es▁will ▁not▁be▁", "eligibl e▁subject", "▁experienc es▁", "direct ly", "▁grade▁ 1", "▁et▁al.▁200 8", "ula ▁vita", "IM S", "list ed▁in▁Section", "s/ SAE", ".\n\nN o", "▁onc ology▁", "▁days▁prior▁to ▁C1", "care▁ physician", "lig and", "▁(m ultiple▁", "▁procedures ▁and▁", "es▁the▁ risk▁of", "▁standard▁ of", "▁remain s▁", ".\n\nIf ▁you", "g/m 2)", "▁JM IG", "▁availabl e", "▁full -dose▁", "▁the▁last▁dose▁of ▁study▁treatment", "▁character ize▁each", "mean ▁QTc", "frequ ently", "astro esophageal▁", "\n\nPh armac", "\n\nPh ysical▁Examination", "▁qual ity", "▁based▁on ▁assessment▁of", ".▁( or▁equivalent", "with▁the▁ exception", ".▁Ex pression", "gener ated", "\n\nEx clusion▁Criteria", "▁clinically▁ relevant", ".\n\nWh en", "PRO ▁endpoint", "▁ext ensive▁", "▁surger y,▁", "▁radiation ▁therapy", "emal e▁", "s.▁S ubject", "outh ▁America", "ogenes is▁", "also ▁been", "\n\n12 .1", "▁chemist ry▁and▁", "propos ed", "79 6", "▁AD MINISTRA", "ouble- blind▁", "▁discus s▁with", "Objectiv es▁", "into ▁the▁study", "▁intraven ously▁", "▁........................................................................ ..", "▁........................................................................ .......▁", "s▁have▁been ▁observ", "▁2▁year s▁after▁the▁last▁dose▁of", "secondary▁ endpoint", "▁immun e▁", "ECOG▁performance▁stat us▁", ".▁There▁ are▁no", "randomis ed▁", "flamm ation▁of▁the▁", ")▁will ▁review", "OC BP", "consent▁form ,▁you", "▁de hydration", ".\n\nAd ditional▁", "breviation s:", "▁by▁the▁ Investigator", ":▁The▁ addition▁of▁panitumumab▁to▁chemotherapy▁(", "▁................................................................ ....", "EL OX", "▁consist ing▁of", "1▁and▁ 8", "SS URA", "previously▁ untreat", "ynops is", "▁AUC ▁=▁area", "begin s▁on", "pen sion", "▁abov e▁or", "▁3▁week s▁after▁the▁last▁dose▁of", "▁future▁ research", "▁3.3 .5", "▁while▁ receiving", ".▁Ch ang", "▁early▁ stopp", "compan y,▁", "▁lead ing▁to", "▁go al▁", "▁hist ology▁", "statistical ▁analysis▁of", "▁IRB ▁or▁IEC", "s.\n\nThe▁ investigator", "▁days▁prior▁to▁randomization ):", "▁of▁5 ▁lesions▁per▁organ", "centr ally▁", ".\n\n.▁T▁N▁E▁M▁U▁C▁O▁D \n\nC▁I▁N▁O▁R▁T▁C▁E▁L▁E", "▁disorder ▁that", "express ed▁in", "\n\nAt ▁least", "shipp ing", "resect ed▁", "▁compens ation", "\n\nAbbreviation s▁and▁Definition", "perman ent", "ate▁( UE", "▁continuous▁ regimen", "▁sequ ela", "-related ▁activities", "consist ing▁of", "included▁in▁the▁ analysis▁of", "▁Stat us", "▁Stat us▁", "▁expect ed▁", "ropo ies", "▁deriv ed▁from", "omat ous▁", "▁participate▁in▁this▁study ,▁you", "▁the▁sign ificance▁level", "sam e▁", "worst ▁pain", "chem ic▁attack", "▁apopt osis▁in", "▁includes ▁all", "▁pemetrexed▁and▁ carboplatin", "pheral▁neuropath y", "Hy d", "▁end▁of ▁study▁treatment▁visit", "orth ▁America", "WBC ▁differential▁(neutrophils,▁", "\n\nArm ▁A", "▁their▁last ▁evaluable▁", "▁Reported▁Outcom es▁", "▁comp eting", ".▁New ▁guidelin", "▁vertebral▁ fracture", "-based ▁therapy", "one▁in ▁Patients▁with", "iss ure", "e▁the▁following :", "recorded▁as ▁adverse▁event", "▁immediate▁ risk▁of▁death", "PPEND IX", "▁alloc ation", "▁relationship ▁between", "-B EING", "▁gene▁ expression", "es▁may▁be▁ collected▁", "concentration ▁in", ".\n\nAmgen▁Thousand▁Oaks \n\nConfidential\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040135▁Date:▁14▁November▁2006\n\nPage▁", "s▁when ▁the▁", "1999 ;", "half -lif", "refer▁to ▁Section", "metab olism", "▁proc ess▁", "\n\nProtocol▁Attachment▁JM HR", "▁Baselin e:", "▁eth ics▁committe", "▁may▁continu 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"▁marker s", "▁ident ity▁", "▁ident ifying", "opy▁ number", "-day▁ period▁", "37 -", "s▁may▁be▁ performed▁as▁clinically▁indicated", "▁such ▁a", "T- 1", "▁mic romol/L", "▁alon e▁in", "baseline▁ valu", "maintain ing", "▁does▁not ▁wish▁to", ".\n\n2 .2", "ing▁in ▁a", "es▁will ▁be\n\n", "▁Dose▁ Level", "safety▁ data", "ousand▁Oak s,▁CA", ",▁an alyz", "air clough", "▁local▁ laboratory", ",▁c apecitabine▁", "▁bod y▁surface▁area", "es▁that ▁are▁not▁confirmed", "hel d▁", "▁physician ▁may▁", "▁Table▁ JMIG", "e▁the▁s mallest▁s", "allow ed", "▁en rolment", "reduc ed▁to", "▁days▁prior▁to ▁Day▁1▁of▁Cycle▁1", "interim ▁analysis▁", "evaluated▁ leading▁to", "\n\nTable▁ 6", "scal e▁", ".▁Wh il", "), ▁time▁to▁progression▁(TTP", "(cid:13 3)", "▁guidelin es▁", "▁and▁d istribut", "▁expos ed▁to", "▁and▁in stitution", "establish ed▁", "therapy ,▁", "best ▁supportive▁car", ",▁patients▁ with", "▁assess▁ disease▁", "ed▁if ▁the▁", "▁path ology▁", ".▁You ▁will", "s▁ar ising", "grad ed▁according▁to▁the▁", "▁Follow ing▁the▁", "oy al▁", "▁will▁be▁administer ed▁", "othel ioma", "▁regard less▁of", "\n\nU pon", "▁participant s▁in", "▁surger y▁or", "equire d▁", "▁Ac cess▁to", "calcium ▁and▁vitamin▁D", "Response▁ R", "performed▁at ▁screening", "regardless▁of ▁whether", "e▁and /or", "every▁3 ▁months▁for", "▁defin ed▁as", "▁evidence▁of ▁progression", "▁the▁interim ▁analysis▁", "dat abase▁", "full y", "enoc arcin", "improv es▁", "improv ed▁to", "........................ ..", "▁Reg istration", "▁calcium ▁and▁vitamin▁D", "immun otherapy", "immun ogenicity", ".▁Treatment ▁Compliance▁", "\n\nx▁x▁x ▁x▁x▁x▁x", "bone▁ marrow", "▁evaluate▁the▁ response▁to", "secondary▁ efficacy▁endpoint", "▁as▁well ▁as▁the▁", "▁small ▁molecul", "▁site▁ personnel", "▁decid es▁", "\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040138▁Date:▁19▁February▁200 8", "▁Overall ▁Survival", "▁the▁pres ent", "e▁dis cover", "▁of▁s ix", "▁co um", "followed▁ every▁", "Drug ▁Administration", ".▁K ris", ".\n\nWhat ▁are▁the▁", "▁had ▁any▁", "▁Evalu ate▁", "▁date▁of ▁death", "unless▁ otherwise▁", "▁frequ ency▁", "ed▁for▁each ▁treatment▁group", "employ ed▁to", "▁evaluate▁ whether", "for▁exampl e,", "correct ▁CRF", "extent ▁of▁your", "▁d▁ n", "Rec or", "▁1.0 ▁Appendix▁Date▁", "efficacy▁and▁ safety▁of", "(C rCl", "\n\nCR \n\nCR", "different i", "▁treated▁ subject", "\n\nGrade▁ 2", "▁intak e▁of", "rest ing▁pulse,▁", "▁dep end▁", ",▁Ch en", "▁identifi ed▁and▁reported▁lesion", "▁Study▁Design ▁..............................................................................................", "ed- RECIST", ".\n\n12 .2", "▁stratifi ed▁log-rank▁test", "s.▁J ▁Natl▁Cancer▁Inst", "▁paragraph \n\nReplace:", "Wild-type▁KRAS ▁Efficacy\n\nAnalysis▁Set", ",▁con stipation,▁", "returned▁to ▁Amgen", "▁worsening ▁of▁", "superior ▁to▁zoledronic▁acid▁with", "▁situ ations▁", "▁central▁ nervous▁system", "most▁common ly▁", "▁malignanc y", "e▁the▁subject ’s▁", ",▁it▁is▁ recommended▁that", "▁Taxol /carboplatin", "REAT MENTS", "▁Disease▁ Progression", "Kaplan-Meier ▁method", "▁action ▁taken", "ed▁through ▁the▁IVRS", "consist s▁of", "omagnes aemia", "eh renbacher", "▁Oxaliplatin /", "ulti- center", "▁serum▁creatinine▁ concentration▁in", ",▁the▁patient ▁will▁be▁", "▁locally ▁advanced▁or▁metastatic", "site▁personnel ▁must", "▁match ed▁placebo", "BJECTIVES ▁........................................................................................................", "revers ible▁", "prob ability▁of", "duration▁of▁ respons", "▁regular ly▁", "▁box ▁number", "while▁on ▁study", "▁ANC ▁<", "▁wher e▁the▁", "portional▁ hazard▁", "▁a▁minimum ▁of▁", ",▁randomized,▁ multicenter", "progressive▁disease▁ will▁be▁", ".▁Pre valence▁of", "VERSE▁EV ENTS", "▁6▁week s▁after", "▁modified▁ RECIST", "▁phase▁III ▁trial", "▁characteristic s▁of", "System s▁", "iagnos is▁of", ".\n\nK▁C▁E▁H▁C \n\nE▁S▁A▁E▁L▁P", ".\n\nK▁C▁E▁H▁C \n\nE▁S▁A▁E▁L▁P\n\n.▁T▁N▁E▁M▁U▁C▁O▁D", "study▁is▁ designed▁to", "adverse▁ effects▁of", ".▁The▁t otal", "have▁a ▁causal▁relationship▁with", "▁deterior ation▁of", "alp it", "▁of▁denosumab ▁with▁zoledronic▁acid▁", "BPI- sf", "▁measure d▁", "objectives ▁are▁to", "▁specifi ed▁", "uls e▁", "ed▁only▁ if", "▁Central▁ Tumor▁Response▁", "applicable▁ law", "analysis▁will▁be▁ censored▁using▁the▁last▁available▁", "e▁sign ature", "comparison ▁of", "Sub cutaneous▁", "▁responsible▁for ▁the▁", ")▁is▁defined▁as ▁the▁time▁from", "ropoi etic", "(9 ):▁p.▁", "member s▁of", "▁satis fied▁with", "▁transient ▁is", "▁how ▁to", "Target▁Lesion s▁", "▁tra uma", "status▁of ▁that▁particular", "▁anx iet", "▁becomes▁ pregnant", "wors ening", "▁or▁its▁design e", "effect▁of ▁AMG▁162", "▁I.V .▁(or▁equivalent", "preserv ative▁", "effect▁of▁ZD4054 ▁on", "International▁Conference▁on▁Harmon ization", "Us e▁of", "most▁recent ▁chemotherapy▁regimen", "examethason e,▁", "]▁and▁ dependent▁children", "appearance▁of▁all ▁non-target▁lesion", "▁on▁day▁1 ▁of▁cycles▁", "discover ies", ".A .,▁et▁al.,▁", "Study ▁to", "eline▁ on", "ramuscular ▁Intravenous▁", "aterials▁and▁ Methods:", "▁authoriz ed▁to", ".▁Report ing", "▁poss ibility▁that", "eleph one:", "\n\nPer cent", "▁some▁cas es,▁", "Is ▁there▁a", "romb ocytopenia", "estimated▁to ▁be▁", " ", "forward ed▁to", "▁Toxic ities▁", "ohistochemistry▁ (IHC", "▁the▁level ▁of", "\n\nAdd▁5 ,6", "\n\nl\n\na ▁c", "FF PE", "s▁(CTCAE )", "one▁scintigraph y▁", "▁2008; ▁83:", "ermat ology", "/S kin", "correlation ▁between", "ation▁of▁Addendum ▁9", "▁suit ability▁for▁accurate▁", "▁supportive▁care▁ al", "ella▁D F", "▁Drug▁Substance▁AZD2171▁Study▁Code▁D8480C00013▁Appendix▁Edition▁Number ▁1.0▁Appendix▁Date▁", "unused▁ portion", "ince▁your▁last ▁visit", "gel ▁capsul", "resid ual▁", ".\n\nCom mon", "▁difference▁ between", "▁taking▁as▁reference▁the▁ nadir", "-minut e▁infusion", "▁mass es▁that▁are▁not▁confirmed", "▁the▁potential▁ for", "signed▁and▁ personally▁dat", "▁assigned▁ study▁treatment", "\n\nEvalu ation▁of", "respiratory▁ rat", "displayed▁graph ically▁", "odd s▁", "e▁definition ▁in▁Section▁4.7.1.1", "▁performed▁at ▁this▁time▁point", "▁Activ ities", "▁(mL/min )\n\n", "▁Head▁and▁Neck ▁Cancer", "/omega-3 ▁ratio", "mac or", "utopsy▁ report", "therton ▁PM", "omega-6 /omega-3▁ratio", "▁to▁prevent▁one▁of▁the▁ outcomes▁", "offered▁ open-label▁denosumab", "elih ood", "▁laborator y▁and▁", "▁demonstrating ▁a▁significant", "▁demonstrate▁a ▁statistically▁significant", ".▁Compar ison▁of", "orld▁Health ▁Organization", "pG▁is land▁", "CONFIDENTIAL \n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁PANITUMUMAB▁(AMG▁954)▁Protocol▁Number:▁20040249▁Date:▁07▁August▁2007\n\nPage▁", "▁and▁post- study▁treatment", "\n\n(continued)\n\n H3E-MC-JM", "▁will▁be▁censored▁at▁the▁date▁of▁the▁last ▁objective▁progression-free▁disease▁assessment", "-E therton▁PM", "jun ctiv", "▁31,▁ 2010", ",▁Wol f", "eplacement▁of ▁Subject", ".▁The▁investigator▁should▁notify▁the▁ IEC/IRB", "s▁-▁Other ▁(", "\n\nFully▁active, ▁able▁to▁carry▁on", "active▁Voice▁Response▁System ▁(IVRS", "▁Practic e▁Guidelin", "▁(Z ubrod", "▁MED IC", "▁rank ▁test", "▁adverse▁event▁report s▁receiv", "▁applicable▁sit es▁of", "▁Access ed▁March", "randomly ▁assigned▁to", "ERIO US", "▁lost ▁to▁follow-up", ".▁Har v", "\n\nCompletely▁disabled.▁Cannot ▁carry▁on▁any▁s", "▁ambulatory▁and▁able▁to▁carry▁out ▁work▁of▁a▁light▁or▁sedentary▁nature,▁", "▁and▁last s▁approximately▁30", "▁20020408▁Amendment▁4 \n\nPage▁", "▁FF PE", "▁signs▁the▁ consent", "▁evaluate▁t ime▁to", "ROQOL ▁EQ-5D", "▁local▁institutional▁practic e),▁", "▁survival▁pro b", "IGNA T", "▁person▁who ▁signs▁the▁consent", "▁of▁5▁lesions▁per▁organ ▁and▁10", "chest,▁abdomen,▁and▁p elvis", "▁Applicable▁ (NA", "olysorb ate▁", "▁unable▁to▁carry▁out▁any▁work▁activities.▁Up▁and▁about ▁more▁than▁50%▁of▁waking▁hour", ".▁Mayo▁Clin▁Proc ▁2008;▁83:", "▁2▁Appendix▁Date▁ 7▁September▁2007", "e▁the▁dose▁by▁ 1▁level", "▁F▁Drug▁Substance▁AZD2171▁Study▁Code▁D8480C00013▁Appendix▁Edition▁Number ▁2▁Appendix▁Date▁7▁September▁2007", "s▁in▁walk ing▁about", "RATOR Y", "s▁with▁performing ▁my▁", "▁must▁personally▁ enter", "▁by▁imaging▁techniqu es▁or", "▁document▁their▁review ▁of▁each▁laboratory▁", "▁compare▁the▁treatment▁effect ▁of▁denosumab▁with▁zoledronic▁acid▁", ".▁Kris -Etherton▁PM", "status▁of▁that▁particular ▁tumor▁for", "▁masses▁that▁are▁not▁confirmed ▁and▁followed▁by▁", "▁document▁their▁review▁of▁each▁laboratory▁ report", "▁compare▁the▁treatment▁effect▁of▁denosumab▁with▁zoledronic▁acid▁ on", "( T", ") .▁This", ", ▁to▁the▁", ", ▁approximately▁", ", ▁through", ", ▁according▁to", ", ▁time▁to", ", ▁the▁data", ", ▁assum", ", ▁thrombocytopenia", "- resistant", ". B", "/ U", "/ week", "0 .05", "1 18", "1 )\n\nIf", "3 1)", ": ▁E", ": ▁H", ": 19", ": 23", ": ▁Th", "; ▁the▁", "A braxis", "B AP", "C ochran-Mantel-Haenszel", "D etermination", "E arly▁", "G 4PFS", "J ournal▁of", "M easurement", "M utant", "M -CSF", "N on", "O c", "O RING", "Q 2-week", "R L", "S erum", "S election", "S ubling", "T D", "T otal▁", "V -", "] )▁and▁", "a ▁N", "a ▁R", "b ad", "b ilirubin", "b ecome▁", "c is", "c ast", "c ough", "c andid", "d am", "e al▁", "f ing", "f raction", "g lob", "g emcitabin", "h CG", "j oint", "l eptomeningeal", "m CRC", "m utant", "o on", "o eb", "p plicable▁", "p ackage▁insert", "p aper", "p attern", "r ill", "r incip", "s per", "s ▁also", "s ▁act", "s ide▁", "s ............................................................................", "s ▁are\n\n", "u i", "u al▁pro", "u NTx", "w ound▁", "w orld", "z ak", "α =0", "” ,▁“", "≥ ▁2", "▁ earli", "▁ even▁if", "▁ ............................................................", "in struction", "▁t ▁i", "at ▁weeks▁", "\n\n J", "\n\n \n\nS", "\n\n data", "\n\n each", "\n\n management", "▁a verage▁", "▁a void", "en larg", "er op", "or ▁p", "or ▁for", "s▁ 1,▁", "s▁ cannot▁be▁", "re ject", "re calculated▁", "▁th roat", "al s", "al ▁and▁", "st rom", "st ated▁", "st atic", "it es▁", "it arget", "▁the▁ E", "▁the▁ assessment", "an ▁K", ",▁ >", ",▁ X", ",▁ discontinu", ",▁ cisplatin", ",▁ using▁the▁", ",▁ EGFR", ",▁ reduc", ",▁ second▁", ",▁ ±▁3▁days", "ro ad▁", "ed▁ log", "ed▁ vial", "ed▁ Dos", "ed it", "ed ical▁", "ed .▁F", "ed ▁and▁the▁", "ed ▁assessments▁will▁be▁", "▁c apacity", "▁c umulative▁", "ing ▁m", "ing ▁investigator", "es ▁the▁s", "for ▁any▁", "▁to ▁3", "▁to ▁perform", "▁to ▁bone▁", "▁to ▁help", "▁to ▁check", "▁to ▁whom", "▁s id", "▁s ec", "▁s atur", "▁s keletal", "▁of ▁Casodex", "th ose▁", "▁m urine▁", "▁and▁ 11", "▁and▁ enter", "▁and▁ cancer", "▁and▁ follow-up", "▁and▁ calcium", ".\n\n With", ".\n\n 22", "el z", "ab solute▁neutrophil▁count", "▁A ppro", "▁A UT", "▁A SSESSMENTS", "▁be▁ evaluated▁leading▁to", "iv es,▁", "▁in ▁NSCLC", "▁in ▁the▁treatment▁of", "▁in stanc", "im pa", "id e▁by", "▁C J", "ac crual", "ac compani", "es▁ at", "es▁ without", "▁P ost", "▁P roduct:", "▁P opulation", "▁P roscribed▁", "il k", "▁( an", "▁( 11", "▁( SC", "▁( by▁", "▁( panitumumab", "▁( except", "▁( weight", "▁( other▁than", "▁( e.g.▁", "▁( i.e.▁", "▁2 +", "ul ated▁in", "ul in-", "con cent", "ra uterine▁", "▁S P", "▁S S", "▁S ubjects▁who", "▁re start", "▁re veal", "ot e▁", "ag e/", "▁D E", "▁D one▁(", "cl ine▁", "ri ef▁Pain▁Inventory▁–▁S", "▁h epat", "▁h appen", "▁l isting", "▁l ater", "▁l iter", "e▁of ▁the▁patient", "▁E ffect", "▁f et", "▁f ast", "▁f easibl", "ch i", "▁or ▁PD", "▁or ▁the▁sponsor", "ir e▁(", "ir regular", "ys p", "form al▁", "\n\nP emetrexed▁", "\n\nP artial▁", "▁n utrient", "per ▁treatment▁arm", "study▁ visit", "▁and ▁approximately▁", "abl es", "▁O ffic", "▁O ’Brien-Fleming", "▁pro m", "▁pro per", "▁pro mis", "all el", "▁T ri", "ep ▁vein", "will▁be▁ present", "will▁be▁ responsible▁for", "will▁be▁ followed▁for", "com part", "▁for ▁you", "▁for ▁women", "▁for ▁Lung▁Cancer", "▁for ▁femal", "▁for ▁evaluating", "▁R BC", "e\n\n th", "e\n\n In", "ed▁in dependent", "▁treatment ▁by▁", "ain dra", "study ▁therapy", "▁with \n\n", "▁with ▁placebo", "▁with ▁modification", "e▁to ▁the▁individual", "ed▁b rain", "ad in", "ad enocarcinoma", "▁that ▁has▁been", "▁that ▁is▁not", "▁is▁ permitt", "▁is▁ preferred", "▁al ive▁", "▁al anine▁transamin", "▁will▁be▁ performed▁at", "eri es▁of", "▁M L", "▁M ember", "▁M ,▁P", "▁M onitor", "▁M ucos", "▁M UGA", "▁con clusion", "▁of▁the▁ adverse▁event", "▁of▁the▁ diluted▁solution", "e,▁ pleas", "▁o per", ".▁The▁ study▁will", "▁g emcitabin", "▁g astric▁cancer", "not ify▁", "▁the▁s urvival", "▁on -", ",▁and▁ (", ",▁and▁ by▁", "▁v itamin▁B12", "▁L A", "▁L imit", "▁L IST▁OF", "▁B A", "▁B E", "▁B iom", "s,▁ in", "▁all ▁SAE", "ure s▁", "▁analys es▁(", "▁analys es▁and▁", "\n\nC ycl", "\n\nC ycle▁", "\n\nC ediranib", "\n\nC linical", "▁5 .4.1", "▁6 .4.2", "ult ras", "▁H g", "▁H ist", "▁H emoglobin", "▁patients▁ will", "▁the▁p emetrexed▁", "▁the▁p re-", ")\n\n 7", "▁at ▁his▁or▁her", "ay lor", "ay \n\nMonth\n\nYear", "s▁( t", "▁study▁ sit", "continu e▁to▁receive▁the▁", "gen otyp", "gen otyping", "gen otype▁", "s.▁ L", "s.▁ St", "rel ev", "▁any▁ SAE", "▁any▁ symptom", "▁any▁ problem", "▁any▁ study-related▁", "▁V EGFR", "▁V ital▁Sign", "▁ex ternal", "▁ex ternal▁", "onth ly▁", "\n\nD uration▁of", "s▁and▁ report", "s▁and▁ risks▁of", "19 )(cid:", "e▁d ifferent", "ly ▁associated▁with", "ob es", "▁patient s.\n\n", "10 ]", "▁the▁d iscontinu", "▁the▁d estruction", "▁the▁d uration▁of", "▁the▁d etermination▁of", "▁the▁d ate▁for", "TI ES", "s▁will▁be▁ used▁for", "▁G oal", "report ed▁for", "▁U rine▁", "▁e ight", "▁tim es▁to", "ies ▁and▁", ".▁P regnancy▁", "\n\nE thics▁", "▁In tern", "▁In jection", "),▁ d", "ed▁by▁ AstraZeneca", "ed▁by▁ Pfizer", "evalu ated▁by▁", "▁is ▁assum", "▁not ▁to", "ON IT", "▁may▁ caus", "▁7 6", "▁7 .8", "▁7 ▁days▁after", "su ant", "▁month ly▁", "▁month s▁and▁", "▁dos ing,▁", "clin ician", "may▁ be\n\n", "s) ▁or", "▁10 ▁mL", "▁10 .6.2", ".6 5", ".6 %)", "▁analysis▁ may▁be▁", ".▁In ▁order▁to", ".▁E nd", "▁assessment s▁are▁", "▁test ▁the▁", "▁test s▁or", "record ed▁at▁baselin", "RA D", "RA Y", ",▁and ▁the\n\n", ".▁C A", "▁cont ra", ".▁T ime▁to", "ed▁with ▁other", "par affin", ",▁or ▁the▁", "▁in▁the▁ United▁States", "e.\n\n 5", "e.\n\n B", "OL OG", "▁9 4", "▁9 6", "EGF ▁receptor", "e▁( IDMC", "first ▁patient", "s▁s upport", "▁each ▁group", "pre -specifi", "pre existing▁condition", "s▁with ▁the▁", "▁data ▁for", "▁data ▁from▁the▁", "▁data ▁cutoff", ").\n\n 8", ".▁If ▁any▁", "▁form al▁", "bas is▁", "ne ither", "ne urolog", "▁the▁investigator ▁believ", "\n\nR eg", "▁your ▁treatment", "Study▁ 200", "▁to▁be▁ obtain", "▁has▁ no", "ass AR", "▁a▁s erum", "▁the▁study .", "▁the▁study .\n\nThe▁", "\n\n3 1", "▁the▁patient ▁population", ".▁D ocetaxel", ".▁D efinition", "▁W BC", ".\n\nA b", "\n\nThe▁ overall", "▁toxic ology▁", "\n\n4 .2.2", ".▁F uture▁", "le eland▁", "ically▁ for", "uc cess", "s▁that ▁the▁", "s▁that ▁have▁", "23 ]", "\n\nI N", "hy persensitivity", "▁visit s▁", "yst al", "car cin", "car e▁but", "▁was▁ unable▁to", "result s▁to", "fl ict", "performed▁ if", "in▁the▁ form", ".\n\nS erum", ")▁ ", "main ▁study▁", "main ten", "patients▁ may▁", "e▁and▁ Events▁", "provid e▁", "urvival▁ Follow-up", "▁An alysis▁Subset", "▁the▁study▁ protocol", "▁must▁be▁ completed", "s: \n\n1", "row n", ".▁R ECIST", "you ▁with", ".▁200 1", ".▁200 3;", "question s▁regarding", "▁the▁subject ▁is▁", "▁the▁subject ’s", "Investigator ▁B", "▁complet ing▁the▁", "▁complet e▁blood▁count", "▁complet eness", "▁this▁study .", "▁this▁study ▁and▁", "▁approximately▁ 462", ",▁P SA", "randomiz ed▁(", "▁treat ing▁physician", "document ▁contains▁", "stat us▁will▁be▁", "▁their ▁own", "▁et▁al ▁2004", "▁ind ivid", "es▁will▁be▁ used▁to", "ed\n\n on", ".▁B oth", ".▁B one▁scan", "response▁ will▁be▁", "▁Panitumumab ▁in▁Combination▁with", "▁receive▁ panitumumab", "▁= ▁creatinine▁clearanc", "▁= ▁intravenous;", "\n\n6 .4.1", "dis pos", "dis card", ".▁M od", ".▁M olecular", "▁Cancer ▁J", "▁event s▁are▁", ",▁s elf-care", "loc ally▁", ",▁200 1", ",▁200 1.▁", "▁may▁be▁ given", "▁may▁be▁ asked▁to", "any▁ other", ".▁H igh", "▁mor e▁frequ", ".2.1 0", "▁non- melanoma▁skin▁cancer", "▁survival ▁data", "▁hour s▁of", "▁loc k", "▁rel ative▁", "▁metastatic ▁colorectal▁carcinoma", "▁result s▁are▁", ",▁b linded▁", ".▁N ature▁", "ext ensive▁", "Wh at", "▁gen eral▁", "▁gen e▁c", "risk ▁of▁", "e▁m etastas", "▁follow-up ▁for", "▁On ly▁", "▁On ly", "\n\nM onitoring", "▁administer ed▁with", "conduct ▁of▁the▁study", "▁respons es", "▁respons ibility▁", ".▁This▁ is▁", "▁to▁ irinotecan", "▁to▁ elimin", "▁baseline▁ assessment", "uthor ities", "▁placebo ▁relative▁to", "▁until ▁disease▁progression▁or", "ogen e", "chang e▁in▁the▁", "chang e▁from▁baseline▁", "ry▁ mouth", "▁this ▁time▁", "plac ed▁on", "▁document ▁the▁", "▁the▁treatment ▁effect", "obtain ed", "lesion s,▁", "▁Clin ic", "by▁ which", "di arrhoea", "▁ne ither", "▁ne utropenic", "▁effect ▁in", ".▁For ▁each", "ZD4054 /placebo", "ed▁by▁the▁ Sponsor", "ype▁ 1▁error", "▁approv ed▁for", "▁plus▁ bevacizumab", "Cons olidation", ".▁I ▁am", "(s) ▁or", "▁within ▁4▁week", "▁Sub set", "fre ez", "start ▁of▁the▁study", "/L illy▁or", "▁this▁study▁ may▁be▁", ",▁G atzemeier▁U", "\n\nL esion", "\n\nL DH", ",▁et▁al .▁The▁", "io id", "research er", "▁allow s▁for", "▁trans forming▁growth▁factor", "▁every▁ 6▁week", "Com mon▁Terminology▁Criteria▁for▁Adverse▁Event", "describ ed▁below", "▁compar e▁Casodex", "\n\nX\n\nX\n\nX\n\nX \n\nX\n\nX", "\n\nX\n\nX\n\nX\n\nX \n\nX\n\nX\n\nX", "\n\ns pecific", "▁at▁least ▁25%", "▁mL ▁of▁0", "Un evaluable▁", ",▁L i", "▁the▁sam e\n\n", "e▁will ▁not▁be▁", "▁24 ▁month", "▁24 ▁and▁48", "indic ated▁in", "▁IV ▁antibiotic", "▁toxicity▁ attributed▁to", "▁Q U", "▁Q uestion", "▁two -t", "DMC ▁will▁be▁", "required▁ for▁the▁", "\n\nO mit", "ate▁the▁ patient", "ability ▁to▁determine▁the▁", "is▁not ▁a", "ual▁ Int", "▁confirm ation", "▁withdraw s▁consent", "▁the▁b lood▁sampl", "at▁least ▁one▁dose▁of", "\n\nStudy▁ Glossary", "ral at", "ism atch", ",▁R am", "▁sp ine▁", "▁cas es▁and▁", "eph ro", "HO RI", "median ▁will▁be▁provid", "analys es▁will▁be▁", "▁symptom s,▁", "▁symptom s▁or", "100 ▁mg", "100 ,000", "▁prior▁to ▁each", "▁serum ▁concentration", "Pro cedure", "▁an▁ emergency▁room", "▁pres ence▁of", "▁pres cription", "▁Con centration", "▁time▁to ▁event", "e/ SD", "post menopausal", "use▁of ▁a", "hyd roch", "reason ably▁", "fficacy▁An alys", "is▁a mended▁", "cycl e▁of", ",▁d eath", "▁further ▁information", "▁X▁X ▁X▁X", "Amgen ▁Thousand▁Oaks", "▁am pl", "▁high ly▁", "▁procedure s▁should▁be▁", "▁days▁after ▁receiving", "representativ es▁of", "anu ary▁", "product ▁or▁for", "▁last ▁dose▁of", ",▁F ossella▁F", "ey ▁are▁", "▁Phase▁ 1", "adverse▁event ▁CRF", "cus sion", "▁carcinoma ▁in▁situ", "▁compl ex", "ing,▁ stor", "ethod▁ with", "e; ▁•", "▁Report ▁Form", "gl utam", "▁scor e,▁", "▁reason s▁for", "plann ed▁for", "olid ▁tumour", "▁throughout ▁the▁study▁", "▁throughout ▁the▁treatment", "▁CTCAE ▁Grade▁3", "develop ing", "3- 9", "▁Confidential ity▁", "▁interim ▁analyses", "▁versus▁ yes", "s; ▁•", "▁the▁f inal▁", "ited▁ data", "▁colon ic", ",▁you ▁should▁", "therapy▁ (", "prof it", "open-label ▁treatment▁phase▁", "ing▁of▁the▁ study", "oler ability", "rang e▁", "ITT ▁Analysis▁Set", "37 .5▁mg", "▁a▁p otential", "▁man ifest", "▁protein s▁involved▁in", "▁improv ed▁", "▁(S GPT", "▁local ized▁", ",▁all ▁effort", "▁Response▁ Evaluation▁Criteria▁in▁Solid▁Tumors▁(RECIST", ",▁E urop", "guidelin es▁in", "guidelin es▁and▁", "pharmac y,▁", "function al", "staff ▁member", "Evalu able▁", "▁demonstr ated", "primary ▁analyses▁of", "rain ing▁of▁", "\n\nNo \n\nSD", "▁known ▁as▁", "HA )", "▁en ough", "read er", "read ing", "▁my▁ famil", "reported▁ if", "\n\nTable▁ JMIG", ".▁At ▁the▁time▁of", "▁and▁D NA", "ires orptive▁", "(cid:13 1)", "s.▁A fter", "(b)▁Confidential \n\nPage▁", "Schedul e,▁", ".\n\nR isks▁of▁a", "-2 20", "▁remain ing", ".\n\n9 .1", "▁exampl e,▁", "▁median ▁survival", "cut off", "cut is/", "\n\nIf ▁a▁patient", "best ▁response▁", "▁a▁subject ▁(or", "▁approval ▁of▁the▁", "▁approval ▁must▁be▁", "EX T", "▁blood▁sampl es▁for", ",▁the▁investigator ▁or▁designee▁will", "stopp ing", "e▁blood▁ [RNA", "▁complete▁ respons", "▁complete▁ response▁", "▁telephone▁ or", "Phase▁ II", "benefit ▁from", ".▁You ▁will▁also▁be▁", "▁necess ary▁", "▁necess arily", "\n\nEx planation", "▁reduction ▁of", ".▁The▁investigator ▁will", "ation▁or ▁special", "available▁ at", "2▁week s▁off", "lymph angitis▁", "▁ext rem", "Data ▁Monitoring▁Committee▁(DMC", "was ▁a", "was ▁associated▁with", "▁written ▁information", "▁written ▁agreement", "1.5 ▁x▁109/L", "followed▁for ▁survival", "\n\nPage: ▁1", "asked▁to ▁sign", "percent ag", "▁return ▁for", "▁systemic ▁anti-tumor", "Grade▁3 /4", ".\n\nLY231514 \n\nH3E-MC-JMHD(f)▁Clinical▁Protocol\n\nPage▁", "ed▁as▁a ▁sterile,▁", ".▁Thes e▁includ", ".▁Thes e▁signature", "necessary ,▁", "hip ping", "measurement s▁(either", "▁the▁discretion▁of▁the▁ treat", ".▁Ther apy▁", "MS S", "Safety▁ follow-up", "brevi ation▁or▁special", "▁AD VERSE▁EVENTS", "\n\ni ▁l", "\n\ni \n\ns▁", "▁request ▁or", "▁anti oxidant", "▁EGFR -", "........................ ......", "▁is▁the▁ responsibility▁of", "s▁must ▁document▁their▁review▁of▁each▁laboratory▁report", "▁direct ▁access▁to", "▁appl y▁to", ".▁The▁patient ▁has", "▁anticancer ▁treatment", "e▁sh ort", "region ▁(Western", ")▁and ▁their", "class ification", "▁independent ▁review", "\n\nNot ▁applicable\n\n", "-T erm", "▁immun ogenicity", "ed▁as▁an ▁AE", "colon ▁cancer", ".▁St atistical▁", "▁Ant igen", "▁Ant iemetic", "s\n\nA ssessment▁of", "es▁a ware▁of", ",▁v omiting,▁", "▁mak e▁a", "▁et▁al,▁200 3)", "has ▁a▁p", "▁Engl ish", "ectom y", "▁As sess", "e▁infusion ▁reaction", "▁Denosumab▁Protocol▁Number:▁20050244▁Date:▁05▁May▁200 8", "Qual ity▁Assurance▁", "▁co oper", "▁Cooperative▁ Group", "Dose▁ Level", "previously▁ received▁treatment▁with", "empt y▁", "▁Sign ificant", "s.▁Th ere▁", "e▁at ▁the▁same▁dose▁level", "▁2▁week s▁of", "▁his/her ▁signature", "ynops is▁", "▁Gen eral", "▁partial▁ response▁(PR", "upper ▁limit▁of▁normal", "s\n\nThe▁ investigator", "ias /d", "▁(if ▁liver▁metastases▁", "▁will▁receive▁ a", "s▁during▁the▁ study▁treatment▁period▁or", "del eg", "▁ent itl", "▁Primary▁ .......................................................................................................▁", "▁anticip ated▁", "Reg istration/", "▁Serious▁Adverse▁Event s▁", "▁refer s▁to", "▁as▁describ ed▁below", "▁antitumor ▁efficacy▁", "positive▁ for", "patients▁who ▁are▁", "▁........................................................................................................ ....", "▁response▁rate▁ (", "▁response▁rate▁ (ORR", "DS MB", "New ▁England▁", "IMC-1121B ▁or▁placebo", "fail ure▁", "ensity▁ (", "access▁to ▁commercially▁available▁", "▁hist ology", "▁hist ologically▁or▁cytologically▁", "▁Guidelin es▁", "▁Reporting ▁Requirements", "withdrawn▁from ▁study▁treatment", "▁of▁C YP3A4", "▁(E rbitux", "\n\nDose▁ Level", "▁Secondary▁ ..................................................................................................", "▁unblind ing▁the▁study", "s.\n\nP age:", "paragraph \n\nAdd:", "▁withdrawal ▁criteria▁are▁met", "\n\nOverall ▁survival", "path ologic", "▁in▁this▁ substudy", "chemist ry,▁", "number▁of▁ vial", "▁preserv e▁the▁", ".▁Clin .▁Oncol", "▁gl ass▁vial", "▁the▁final ▁analysis", "▁el ev", "\n\nDiscontinu e▁bevacizumab", ").\n\nS ubject", "▁increased▁ risk▁of", "▁Stat ement", ".\n\nTh es", "▁Pemetrexed▁ plus▁", "▁5% ▁significance▁level", "s▁are▁not ▁required", "raw ford▁", "eft ▁ventricular", "▁d▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Panitumumab▁Protocol▁Number:▁20050203▁Date:▁21▁January▁2009\n\nPage▁", "monitoring ▁visit", ".▁Onc e▁", ".▁Onc e▁the▁", "▁the▁pre ceding", "withdrawal ,▁or▁death", "▁supplementation ▁reduc", "e▁the▁in cidence▁of", "s▁involv ing", "▁of▁16 \n\nVersion", "▁previously ▁treated▁with", "\n\nAdverse▁Event s", "laborator y▁and▁", "▁Event ▁Goal", "▁approximately▁30 ▁minutes", "▁(0 )", "intraven ous▁", "general ized▁", "▁unit s▁or▁term", "utiliz ed▁to", "▁Procedures▁for ▁discontinuation", "publish ed,▁", "▁Up date▁", "radiotherapy▁ for", "pemetrexed▁ 500▁mg/m2", "recover ed▁from", "▁modified▁ RECIST▁criteria", "▁clos ely▁", "30-day▁postdiscontinuation▁follow-up ▁period", "eryth ropoietin", "▁prostat e-specific▁antigen", ".▁In▁the▁event ▁of", "▁statistical ▁analysis", "90% ▁power▁to▁detect", "power ▁to▁detect", "Int ent", "▁anti-cancer ▁therapy", "▁Randomized,▁ Multicenter", "▁ep isod", "urr ence▁of", ".▁Rec ord", "▁repe ated▁", "(4 ):", "24-month ▁treatment▁phas", "astrointestinal ▁perforation", "\n\nN▁A\n\nF▁O\n\nY▁P▁O▁C \n\nD▁E▁T▁N▁I▁R▁P\n\nA\n\nS▁I\n\nS▁I▁H▁T", "▁purpos es", "yes▁ vs▁no", "investigational ▁drug", "ream lin", "applicable▁ regulatory▁requirement", "▁Backgroun d", "uroto xicity▁", "BSC ▁arm", "▁and▁the▁investigator ▁agree▁to", "▁will▁be▁the▁ primary▁", "interfer e▁with", "therapy▁for ▁metastatic▁colorectal▁cancer", "▁fracture▁ (", "▁suggest ▁that", "arc oid", "reported▁on▁the▁ CRF", ",▁panitumumab ▁was▁removed▁from▁the▁regimen", "▁or▁d evic", "▁FDA ▁1572", "RAN K", "▁its elf", "-free▁ rates▁", "▁biological ▁samples", "\n\nUE /ND", ",▁ther efore,▁", "Japan ▁only", "▁(FOLFOX )", "ortality▁ in", "▁abnormalities ,▁and▁", "commer cially", "▁plot s▁of", "▁ensur e▁the▁", "▁eryth ropoietin", "(mg )▁=", "wors en", "imilar▁to▁that ▁of▁the▁", "Wild-Type▁KRAS ▁Efficacy▁Analysis▁Set", "▁within▁30 ▁days▁of", "▁regulatory▁ report", "International▁Conference▁on▁Harmon isation▁(", "pending ▁function", "clinical▁data ▁management", "▁change\n\n No", "Cox ▁model", "▁advant age▁", "commun ication", "ultiv itamin", "\n\nOb jectiv", "\n\nOb jective▁", ",▁Johnson ▁DH", "▁primary▁tumor ▁is▁", "e.▁M easurement", "stein ▁L", "▁concent rate▁for▁solution▁for▁infusion", "▁antif olate▁", "▁antif ungal", "easurabl e:", "Response▁( PR", "deliver ed▁over", "steroid al▁anti-", "▁candid ates▁for", "its elf", "imer ic", "ribonucle ic▁acid", "▁non-metastatic ▁prostate▁cancer", "▁as▁a▁result ▁of", "down ▁of▁this", "▁SY ST", "▁Elect ronic", "ed▁by▁Amgen ▁Inc", "▁time▁to▁first ▁on-study▁SRE", "experimental ▁arm", "Each ▁person▁who▁signs▁the▁consent", "▁se em", "▁syn thes", "▁Review ▁of", "ryth ema", "s▁identifi ed▁at▁baselin", "proportion s▁of", "▁change▁of ▁lumbar▁spine▁BMD", "contribut e▁to", "100% ▁dose▁level", "\n\nanalysis▁ set", "s▁may ▁also▁be▁", "▁or▁l ess▁in", "▁or▁his/her ▁designee▁", "(10 ):▁p.▁", "▁1▁( baselin", "▁hyd ration", ".org /", ".▁In▁this▁ cas", "▁authorized▁representativ es▁of", "\n\nA▁® \n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040138▁Date:▁19▁February▁2008\n\nPage▁", "serious▁ AE", ".▁DATA ▁ANALYSIS", "▁the▁beginn ing▁of", "ECOG▁performance▁status▁(0 ▁or▁1", "PECI AL", "PECI FIC", "-Reported▁Outcom es▁(PRO", "healing ▁complication", ".▁Br ▁J", "restrict ed▁to", "▁Independent ▁Data▁Monitoring▁Committe", ".▁Elig ibl", "▁neuroto xicity", "ability,▁ withdrawal,▁or▁death", "▁the▁subset▁of▁subject s▁in▁the▁ITT", "abet es,▁", "unequivoc al▁progression", "▁vir us", "identified▁as▁ non-target▁lesion", "Brief▁Pain▁Inventor y▁(BP", "same▁m ethod▁of▁assessment", ".\n\nWill ▁I", "▁are▁th ose▁", "Rest ▁of▁World", "▁post-baseline▁ PRO▁assessment", "▁red act", "▁review▁and▁ meta-", "\n\nSection:▁Protocol ▁Synopsis", "decid e▁to", "▁antihist amin", "pulmon is", "▁mes othelioma", "undergone▁ a", "Pleas e▁", "▁should▁notify▁ your▁doctor", "▁Epidemi ology,▁", "e▁indicate▁ how", "funding ▁this▁clinical▁study", "▁ever ▁comes▁first", "y/illness ▁that▁is▁", "erbst ▁RS", "▁ascites,▁ pleur", "single▁ agent", "i-squ ar", "used▁for▁any▁purpose▁ other▁than▁the▁evaluation▁or▁conduct▁of▁the▁clinical▁investigation", "\n\nPage:▁36\n\nSection:▁2.3.6.6,▁Anti-Panitumumab▁Antibodies ,▁third▁", "terim▁Analysis▁and▁Early▁Stopping ▁Guidelines", "one▁or▁more▁of▁the▁following :", "hold▁dose▁until▁toxicity▁is▁ grade▁", ",▁week ▁13", "▁l-L V)", "patient▁hospitalization▁or ▁prolongation▁of▁existing▁hospitalization", "▁data▁monitoring ▁committe", "fractur e▁during▁the▁", "▁synerg istic", "epherd▁ FA", "▁measurable▁lesions▁up▁to▁a▁maximum ▁of▁5▁lesions▁per▁organ▁and▁10", "pase- 3", "reed man", "▁cynomolgus▁mon keys", "ampt oth", "per- protocol", "consisting ▁of▁", "▁Individual▁ Subject", "205- 216", "▁WIT H", "mClone /Lilly▁or", "dentification ▁Number", "obility ,▁self-care", "EDTA▁blood▁[plasma▁and▁cell ▁pellet],▁PAXgen", "▁source▁data ▁verification", "▁prematur e▁discontinu", "▁imaginable▁ health▁stat", "\n\n5\n\n6\n\n7\n\n8\n\n9 \n\n10", ".▁Stat ▁Med▁", "▁150▁mg▁once▁daily▁ with▁placebo▁in▁terms▁of", "▁other▁lesions▁(or▁sites▁of▁diseas e)", "▁20040135 \n\nPage▁", "lymph▁node▁is▁N 0", ".▁Proceedings▁of▁the▁ National▁Academy▁of▁Sciences▁of▁the▁United▁States▁of▁America", "/infusion -related▁reaction", "iec ew", "oembryonic ▁antigen", "▁Subject▁Information ▁Sheet", "▁(multiple▁ event▁analysis", "▁racem ate▁(or", "▁Key▁Study▁ Endpoints", "▁sufficient▁shrinkage▁to▁qualify▁for▁PR▁nor ▁sufficient▁increase▁to▁qualify▁for▁PD", "wart z", ",▁intoler ability,▁withdrawal,▁or▁death", "s▁and▁mutant▁KRAS ▁tumor", "1-Day▁ Cycl", "inal▁Investigational▁Product ▁Reconciliation", ".\n\nTREATMENT ▁PROCEDURES", "recommended▁but▁not ▁required", "ehrenbacher ▁L", "portional▁hazard▁ model", "ermatology /Skin", "macor ®", "▁(Zubrod )", "▁must▁personally▁enter ▁the▁date▁for", "▁by▁imaging▁techniques▁or ▁clinically", "▁masses▁that▁are▁not▁confirmed▁and▁followed▁by▁ imaging▁techniqu", "oeb el", "erop ol", "es▁the▁s mallest▁s", "▁AUT HORI", "▁Done▁( ND", "aindra ult", "ONIT ORING", "assAR RAY", "▁compare▁Casodex ▁150▁mg▁once▁daily▁with▁placebo▁in▁terms▁of", "ual▁Int ramuscular▁Intravenous▁", "product▁or▁for ▁up▁to▁2▁year", ",▁all▁effort s▁will▁be▁made▁to", "raining▁of▁ staff", "cutis/ pulmonis", "breviation▁or▁special ▁term", "New▁England▁ Journal▁of▁", "access▁to▁commercially▁available▁ product▁or▁for▁up▁to▁2▁year", "▁of▁16\n\nVersion ▁Date:▁14▁November▁2006", "down▁of▁this ▁analysis▁set", "obility,▁self-care ,▁", "▁must▁personally▁enter▁the▁date▁for ▁his/her▁signature", ") ▁as", ") ▁which", ") ▁is▁a", ") .▁If▁the▁", ", ▁to▁be▁", "- point", "- 24", "- 33", "- 27", "/ renew", "0 .025", "1 ).\n\n", "1 ▁vs▁", "2 _", "3 54", "3 80", "4 ▁mg", "7 ▁days", "8 .3", ": 10", ": ▁p.▁", ": ▁Patients▁", ": ▁To", "; ▁serum", "@ may", "A merican▁BioScience,▁Inc", "B I", "B U", "C olon", "D iction", "E PA", "E AR", "E ffect", "F WB", "G -CSF", "G ENC", "H IV", "H ,▁L", "H ead", "J ,▁C", "L os", "L EX", "M easurable▁Lesion", "N OT", "N -telop", "P IN", "P ET", "R )", "S LD", "S NP", "T itle:", "U BL", "W H", "W ork", "a ▁t", "a ortic", "b road", "c illary▁", "d epend", "d aily", "d emographic", "d yspnea", "d one▁in", "e \n\nAny", "e (s)\n\n", "f ect", "f easibl", "f riend", "g ina", "g emcitabine-cisplatin", "i ul", "i ew", "k ull", "k etoconazol", "m etic", "m aterial▁", "o ▁A", "o edema", "p ound", "p alli", "p alpable▁lymph▁nod", "r and", "r ▁o", "r ▁e▁", "s ▁the▁patient", "s \n\nSt", "s ....................................................................................", "s chema", "t a", "t aking", "u ▁m▁u", "v ad", "v arian", "v inorelbine▁", "x 2", "x ▁109/L", "x enograft", "… …", "▁ z", "▁ utility▁", "▁ emergency▁", "▁ elective▁", "▁ early▁termination", "▁ occasion", "▁ β-", "e▁ N", "e▁ •", "e▁ level", "in i", "in ▁2", "in ary▁", "in formed▁", "in eph", "in ner", "in ▁terms▁of", "in surance▁", "at om", "at e,", "on ▁study", "on ym", "on e▁that", "on e▁of▁the▁following", "\n\n :", "\n\n ", "\n\n all", "\n\n other", "\n\n progression", "\n\n any▁", "\n\n chang", "\n\n Up", "\n\n ECG", "▁a ▁D", "▁a ▁dose▁of", "▁a ▁total", "▁a ▁difference▁in", "▁a ▁number▁of", "▁a ▁protocol▁amendment", "en abl", "en ne", "en erg", "or al▁", "or egion", "........ ....", "s▁ under", "s▁ where▁", "s▁ upon", "s▁ ..................................................................................................", "s▁ consistent▁with", "s▁ ..............................................................................", "s▁ regarding▁the▁", "re paration", "al m", "al ▁of▁the▁", "al tern", "st aging", "ent ry▁", "ent ries", "it a", "it ely▁", "it ▁should▁be▁", "▁the▁ D", "▁the▁ evaluation▁of", "an imal", ",▁ 50", ",▁ 17", ",▁ 13", ",▁ 16", ",▁ each", ",▁ ORR", ",▁ prostat", ",▁ whether▁or▁not", "ed▁ immediately", "ed▁ chemotherapy▁and▁bevacizumab", "▁an alog", "▁an ▁observed▁", ".▁ 28", "ar com", "ed ▁tim", "ed ing,▁", "▁p ress", "▁c opies▁of", "▁c aution", "ing ▁it", "ing ▁•", "ing ▁informed▁consent", "ing ▁whether", "▁b )", "▁b io", "▁b order", "▁b roken", "▁b usiness▁", "for ▁whom", "▁to ▁us", "▁to ▁report", "▁to ▁consent", "▁to ▁include▁", "▁to ▁measur", "is ed", "is 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"iz ed▁for", "ex plan", "ex pir", "ec in", "▁n ever", "od y", "\n\nA vastin", "study▁ enrollment", "study▁ personnel", "study▁ specific", "▁O mega-3", "▁as partate▁transamin", "▁pro moter", "▁T RIAL", "▁T axotere®", "▁ad enocarcin", "ep isod", "ep resent", "op ic", "op iate▁", "will▁be▁ used▁for", "ast olic", "com puted▁tomograph", "▁for ▁information", "▁for ▁men", "▁for ▁submission", "▁for ▁more▁detail", "and book", "▁R est", "▁R ecommendation", "ed▁in ▁this▁protocol", "▁treatment ▁of▁", "▁treatment ▁emergent", "study ▁therapy▁", "▁with ▁all", "s▁of ▁disease▁", "In sert", "ant on", "ant ▁to", "▁200 2;", "▁is▁ of", "▁is▁ us", "▁is▁ observ", "▁is▁ recommend", "▁is▁ considered▁", "▁of▁ radiation", "▁will▁be▁ includ", "▁will▁be▁ followed▁for", "▁will▁be▁ based▁on▁the▁", "e▁s et", "eri al", "e▁th is", "▁0 .1", "▁0 .33", "▁3 50", "▁3 ▁days", "▁3 .10", "event s▁are▁", "e,▁ F", "▁com puted▁tomograph", "▁F il", "▁F olic", "▁F att", ".▁The▁ New▁England▁Journal▁of▁", "▁g row", "not ified▁", "200 2;", "▁the▁s um", "▁the▁s erious▁adverse▁event", "▁on ▁placebo", "▁on go", ",▁and▁ s", "▁L ong", "able▁ disease▁", "▁B H", "▁B est", "▁this▁ endpoint", "s,▁ ECG", "s,▁ 2004", "s,▁ regulation", "▁all ▁the▁", "▁res cu", "12 ]", "12 ▁month", "▁st im", "\n\nC alcium", "▁ch em", "▁ch romosom", "▁will ▁review", "▁will ▁consist", "▁will ▁undergo", "e▁in dex", "ing▁the▁ investigator", "▁5 ▁mg/kg", "▁6 00▁mg/m2", "ult im", "▁H IV", "and▁ who", "▁patients▁ randomized▁to", "▁4 .5", "▁4 ▁weeks▁", "▁4 -week", "▁4 .10", "▁the▁p ain", ")\n\n 1", "▁at ▁this▁", "ampl es▁will▁be▁", "andomiz ed,▁", "s▁( P", "s▁( Appendix", "s▁( i.e.,▁", "▁the▁in vestigation", "▁ac et", "▁ac ros", "eg ment", "eg rad", "▁study▁ closure▁", "continu ing▁on", "\n\n1 .\n\n", "\n\n1 Each▁person▁who▁signs▁the▁consent", "vi x", "po ons", ".5 0", "ens e▁", "▁ex ist", "▁ex hibit", "▁the▁t umour", "\n\nD ate\n\n", "▁after ▁a", "▁after ▁the▁last", "▁after ▁the▁first", "ation▁of ▁major▁body▁system", "ed▁for ▁response▁assessment", "s▁and▁ In", "s▁and▁ Amgen", "e▁d efin", ".▁S om", ".▁S ign", ".▁S piral▁CT", "▁the▁d ate▁th", "▁the▁d etail", "▁the▁d istribution", "▁G l", "▁G MT", "▁un known", "report ▁the▁", "report ▁accurately▁", "▁U pon", "▁U sing", "▁J F", "▁J ,▁K", "▁Number ▁of", "▁Number ▁of▁Center", "▁tim e", "▁tim e,▁", "▁tim e:", "▁tim e-", ".▁P ain", ".▁P emetrex", "▁In ▁the▁", "▁from ▁your", "▁is ▁this▁document", "▁may▁ be\n\n", "▁7 1", "▁7 0%", "▁month s▁and", "▁dos ing▁and▁", "▁dos e▁should▁be▁", "ction ▁taken", "ost erior", "CT EP", "▁adverse▁event s,▁including", "▁adverse▁event s▁(including", "▁per ▁local", "str ateg", "▁10 .3.1", "ibl e▁to", ".6 ▁month", "▁to▁the▁ last", ".▁In formed▁Consent▁Form", ".▁In ▁general", "so ver", ".▁E n", ".▁E very▁effort▁should▁be▁made▁to", "▁ag gregate▁", "▁test ing▁for", "ated ▁as▁", "record ed,", "record ed)", "record ed▁since▁the▁treatment▁start", "s.\n\n Confidential\n\nPage▁", ",▁and ▁agree▁to", ".▁C aus", ".▁C isplatin", ".▁C alcul", "11 5", "11 ]", ".▁T est", ".▁T abl", "par onychia", "’s▁ effect", "drug ▁accountability▁", "▁in▁the▁ following", "e.\n\n 2", "e.\n\n 4", "ary ▁and▁", "▁9 1", "▁9 5", ".,▁ C", "MG MT", "articip ating", ").\n\n D", ".▁If ▁this▁", ".▁If ▁you▁are▁", ".7 1", "\n\n2 .", "\n\n2 .\n\n3", "▁should▁be▁ contact", "▁should▁be▁ provided▁to", "ari o", "▁lesion s▁in", "▁the▁investigator ▁to", "▁the▁investigator ’s▁assessment", "\n\nR emoval▁of▁Subject", "▁your ▁DNA", "▁Ad ministration▁of", "▁pre caution", "ed▁as▁ well", "▁Study▁ JM", "▁you ▁receive▁", "▁cycl es)", "\n\nT rial▁", "\n\nT raining▁of▁staff", "e, ▁the▁day▁of", "\n\n3 7", "\n\n3 .7", "sh op", "▁the▁patient ▁has▁been", "▁The▁ patient", ".▁D eath", ".▁D id▁", "s▁are▁ being", "▁dose▁ or", "▁dose▁ for", "▁W ill", "▁W orld▁", "e) ▁for", "\n\nThe▁ patient", "I- GI", ".\n\nP h", "e▁b one▁", "▁therapy .", "13 3", ",▁S D", "▁visit ▁for", "defin ed▁by▁the▁", "▁it u▁m▁u", "▁therapy▁ should▁be▁", "es,▁ which", "result s▁are▁", "▁act ually▁", "performed▁ when", "administ 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22", "rof olate▁", "▁Treatment ▁Arm", "▁Treatment ▁Arm▁B", "▁measurement s▁of", "▁the▁end▁of ▁study", "chemotherapy ▁and▁", "stor ed▁in▁the▁", "\n\nAdd▁ 12", "▁20 ▁mg/mL", "▁phase▁ 1", "most \n\n", "most ▁severe▁", "▁is▁not ▁consider", "y▁s can", "........................................................ ...▁", "▁AND ▁S", "▁AND ▁PROCEDURES", "▁thes e▁two", "▁advanced▁ HNC", "); ▁and▁", "Ex perience▁", "Ex clusion▁Criteria", "▁mg/kg ▁to", ".\n\n6 .3", ".\n\n6 .4", "dependent ▁on", "▁contain s", "▁CA SE", ".▁Ad ministration", "pothes is", "Pro ject", "▁PD ▁PD", "ance▁of ▁approval▁must▁be▁", "▁an▁ optional", "▁an▁ outpatient", "▁prior ▁bevacizumab", "▁Con tinu", "▁sunitinib ▁administer", "▁Grade▁ ≤", "withdraw al▁of▁consent", "e/ carboplatin", "mor ning", "y▁( or", "2- year", "off -F", "central▁ lab", "▁caus e▁of", "▁caus ality▁", "▁human ▁tumor", "▁human ▁immunodeficiency▁vir", "reason able▁", "reason s▁for", "reason (s)", "clos ure▁of", "▁record ed▁since▁the▁treatment▁start", "ated▁in 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"▁clinical▁trial s▁in", "▁Safety▁ Analysis▁Set", "37 .5", "e,▁the▁ report▁accurately▁", "accept abl", "▁oxaliplatin ▁or▁irinotecan", "▁the▁dis pens", "procedures ▁and", "need ed", "second -line▁", "es▁that ▁I", "▁“ yes", "▁function ,▁as▁follows▁(≤", "direct ly▁to", "hel d", "................................................................................................................ ....", "\n\nConfidential\n\nAMGEN \n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁AMG▁162▁Protocol▁Number:▁20040135▁Date:▁14▁November▁2006\n\nPage▁", "▁et▁al.▁200 6", "health ▁status▁", "▁known ▁to▁be▁", "urin ary", "▁6▁month s▁prior▁to", "▁minimum ▁of▁", "▁(P RO", ".▁5 3", ".▁On e▁", ".▁On ly", "important ▁for", "important ▁to▁the▁", "important ▁medical▁event", "histor y", "metastatic ▁disease▁", "metastatic ▁colorectal▁cancer", "activ ities", "▁guidelin es▁for", "▁k ept", "common ▁(", "s.▁A bstract", "schedul e▁", "schedul ed▁visit", "▁post discontinuation", "Schedul e", "\n\nb one▁", "89 ;", ",▁O ’", "▁involv es▁", 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olinic▁acid▁", "▁f avour", "ver tebra", "ch olesterol", "▁or ▁to", "▁or ▁as▁", "▁or ▁in▁the▁", "▁or ▁prior", "▁or ▁local", "▁or ▁FOLFIRI", "▁or ▁equivalent", "ther eafter", "ther e▁is▁", "\n\nP rior▁to", "\n\nP ostdiscontinuation", "\n\nP roscribed▁", "iz es▁", "ex cretion", "ex acerb", "ex plicit", "▁n ons", "▁n erv", "▁n ▁d▁", "▁n ominal▁significance▁level", "ist inct", "ist rar", "od ilator", "\n\nA UC", "\n\nA ss", "study▁ may▁be▁", "▁and ▁after", "▁and ▁administer", "▁O ’Brien", "▁O UTC", "▁as ▁a▁s", "▁as ymptomatic", "▁as ▁a▁serious▁adverse▁event", "▁pro ced", "all point", "all ▁Street", "▁T umour", "▁T otal▁", "▁T el:", "▁T itle:", "▁T REATMENTS", "ep ist", "ep idemi", "ep igenetic", "op ies▁of▁the▁", "ef ract", "com /", "com mence▁", "▁for ▁PFS", "▁for ▁both", "▁for ▁review", "▁R ul", "▁R isk", "▁R EG", "▁R oyal▁", "ib b", "e\n\n 1", "e\n\n subject", "e\n\n treatment", "rom boembolic", "ed▁in dividual", "▁treatment ▁and", "▁treatment ▁on", "▁treatment ▁option", "▁treatment 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emcitabine-cisplatin", "▁are▁ un", "▁are▁ cons", "▁are▁ responsible▁for", "▁are▁ plann", "▁are▁ available▁", "▁are▁ clearly▁", ",▁and▁ 5", ",▁and▁ 15", ",▁and▁ institution", ",▁and▁ reproduc", "ly▁ interval", ".3 ).\n\n", ".3 \n\nSampl", "ever ▁possibl", "▁B Y", "▁B EN", "▁B io", "▁this▁ regimen", "s,▁ even▁if", "s,▁ 1999", "af let", "▁all ▁study▁medication", "12 6", "12 9", "out ▁Panitumumab", "▁analys es▁are▁", "▁st ill▁be▁", "▁st ate▁you", "ial ▁pneumon", "ach ine▁", "\n\nC ollection", "\n\nC ase▁Report▁Form", "\n\nC ollection▁of", "\n\nC hemistry▁panel:▁sodium,▁potassium,▁chloride,▁bicarbon", "▁will ▁monitor", "▁will ▁go", "ing▁the▁ patient", "ity ,▁an", "▁6 4", "▁6 00", "▁6 ▁weeks▁", "▁6 .10", "▁H L", "▁H owever", "▁H ematology▁", "and▁ subject", "▁patients▁ enter", "▁patients▁ only", "▁4 .2.1", ")\n\n L", "▁at ▁any▁time▁", "s▁( s", "s▁( see▁Appendix", "▁the▁in creas", "▁the▁in dividual▁", "eg al▁", "eg uard", "▁study▁ data", "▁study▁ staff", "▁study▁ withdrawal", "continu ously", 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▁biomarker", "▁may▁ feel", "▁7 8", "su ffic", "▁dos e,▁the▁", "effect s▁on", "pres cription", "pres cribe▁", ",▁the▁ DMC", "▁study ▁therapy,▁", "may▁ begin", "▁adverse▁event s▁that", "▁per ▁arm", "▁per ▁day▁", "▁per ▁lin", "e▁v ari", "pect rum", "includ e▁the▁", "includ e▁all", "str ength", "s) ,▁and▁", "s) ▁should▁be▁", "s) ▁until", "▁to▁the▁ next", "▁analysis▁ on", ".▁In ▁this▁study", ".▁In ▁case▁of", "▁assessment s▁and", "▁test s▁(", "18 ▁year", "ated ▁and▁destroy", "record ed▁", "over ▁time▁", "s.\n\n .▁T▁N▁E▁M▁U▁C▁O▁D", "s.\n\n Pro", ",▁and ▁treatment", ",▁and ▁the▁day▁after", "AL ▁PRODUCT", "▁ab sent", "▁ab ide▁by▁all", "peri pheral▁", "’s▁ “audit▁trail", "▁x ▁ic", "20 )(cid:", "ed▁at ▁screening", "▁in▁the▁ model", "▁in▁the▁ first-line▁treatment", "▁in▁the▁ opinion▁of▁the▁investigator", "▁in▁the▁ Treatment▁of▁Bone▁", "e.\n\n 7", "e.\n\n C", "e.\n\n All", "patient ▁who", "): 5", "▁8 .9", "▁8 00▁IU", "e▁( eg,▁", "▁us e▁during▁the▁", "mit age▁", "\n\nProduct: ▁Denosumab▁Protocol▁Number:▁20050136▁Date:▁30▁April▁2008", "\n\nN ▁H", "\n\nN SCLC", "▁each ▁assessment", "▁each ▁dose▁of", "▁each ▁radiological", "▁X ▁D", "▁X eloda", ").\n\n 9", ").\n\n If", ".▁If ▁the▁true▁", ".7 8", "\n\n2 7", "\n\n2 9", "\n\n2 .\n\nTo", "▁form at", "bas aju", "▁should▁be▁ destroy", "ark ed▁", "▁your ▁partner", "ind ividual▁", "▁Ad verse▁Drug▁Reaction", "▁the\n\n study▁", "▁pre clinical▁data", "ed▁as▁ soon▁as▁possibl", "▁Study▁ S", "▁the▁study ▁team", "▁cycl ooxygen", "\n\nT im", "e, ▁an", "rial▁ fib", "\n\n3 9", "000 ▁g", "sh ine▁", "▁the▁patient ▁was▁", "▁the▁patient ▁and▁the▁investigator▁agree▁to", "dra ft", "▁addition ally▁", ".▁D o", "no ▁additional", "s▁are▁ administer", "▁dose▁ interruption", "▁W e▁", "▁W il", "▁than ▁in", "pr urit", "e) ▁is▁", "ed▁in▁the▁ course▁of", "\n\n4 .5", "le b", "data ,▁and▁", "data .▁Direct", "▁mg/m l", ",▁S z", ",▁S .,▁et▁al.,▁", ",▁S omer", "▁visit s,▁", "defin ed▁and▁", "lind ing▁and▁", "s▁or ▁addition", "▁was▁ reported▁in", "in▁the▁ range▁of", ")▁ –", "main ly▁", "e▁treatment ▁arm", "▁progression ▁free▁survival", "▁evalu ated▁", "e▁and▁ disclosure▁of", "sign ed▁by▁the▁investigator▁or", "sign ,▁symptom", "urvival▁ follow-up", "ed▁and▁ un", "ed▁and▁ dated▁in", "▁di ary", "▁the▁study▁ must▁be▁", "▁the▁study▁ records▁to", "may▁be▁ used▁for", "s: \n\n\n\n", "▁sampl es▁from", "▁infusion -related▁reaction", "row ley▁J", "▁13 .5", "▁13 5:", ".▁R ational", "SA BP", "ND OMI", ",▁a ▁regulatory▁author", "ed▁from ▁a", "▁sit e▁will▁be▁", "▁sit es▁will", "▁cell ▁lung", "▁subjects▁ per", "▁subjects▁ enroll", "▁subjects▁ were▁", "Investigator s▁", "Investigator ▁should▁", "\n\nH R", "\n\nH &N", "discontinu ed▁", "discontinu ed▁if", "▁Com pensation", "▁approximately▁ 100", "ed.\n\n If", "▁discontinu e▁b", "St ruct", "valu e▁", "valu es▁may▁be▁collected▁", "\n\n\n\n is▁a", "document ed▁in▁a", "▁CT ▁Scan", "▁et▁al ▁2003", ",\n\n respectively", "eb b", "eb y▁", "▁and/or ▁AstraZeneca", "▁continu ation", "▁Panitumumab ▁Preclinical▁", "es▁in ▁relation▁to", "ed▁s eparately", "▁receive▁ any▁", "collect ed▁using", "▁occur s:", "▁occur s▁after", ")▁and▁ cisplatin", "▁Page▁ 15", "▁disease▁progression ▁is▁suspect", "16 ]", ",▁s om", "▁these▁ analys", "mod ified▁as▁", "atist ical▁and▁", "s▁b eing", ",▁M .,▁et▁al.,▁", ",▁M endelsohn", "\n\n7 0", "▁dis c", "elect ronically▁", "ha ematology▁and▁", "any▁ caus", ".▁H ospitalization", "arr hyth", "-rel ated▁injur", "mall ▁cell▁lung▁cancer", "▁drug ▁exposure▁", "▁drug ▁abus", "s▁will ▁remain", "▁through ▁a", "easur ability▁of", "▁must ▁have▁been", "▁loc ation,▁", "1- 14", "▁(A JCC", "administer ed▁with", "sub mit", "1) .▁The▁", "▁metastatic ▁prostate▁cancer", ".9 9", "ation▁of▁ “", "norm ally▁", "\n\nIn formation", "\n\nIn vestigational▁product", "▁stat us▁in", "IN AL▁PRODUCT", "▁gen es", "Ad juvant", "e▁m icroar", "▁by▁ mouth", "▁– ▁Arm▁B", "▁– ▁general", "\n\nM onitor", "▁can ▁imag", "▁administer ing", "▁administer ed▁for", "conduct ed▁as▁", "▁information ▁and▁", "▁number ▁per▁lin", "given ▁over▁2▁to▁4", "clinical▁ studies", "clinical▁ judgment", "▁tissu es", "▁tissu e▁section", "▁administration ,▁", "OS ▁and▁PFS", "▁ID MC", "were▁ conduct", "▁there▁ ar", "▁there▁ have▁been", "ities ;", ".\n\nThe▁ principal▁investigator", "▁des ired▁", "K▁C▁E▁H▁C \n\nE▁S▁A▁E▁L▁P\n\n.▁T▁N▁E▁M▁U▁C▁O▁D", "obtain ed▁for", "obtain ▁approval▁from", "ing▁of ▁biological▁samples", "▁17 .1", "lesion s▁will▁only▁be▁", "studies▁ in", "by▁ Amgen", "-5 8", "each ▁statement", "▁radi ologist", ".▁J .▁Clin.▁Oncol", ".▁J ▁Urol", "panitumumab ▁administration", "information ,▁", "▁CR ▁PR", "urn bull", "must ▁not", ".▁For ▁patients▁who", "\n\nAn t", "ed▁by▁the▁ central▁laboratory", "▁• ▁D", "▁plus▁ prednisone▁", "es▁and▁ monocyt", "es▁and▁ Technical▁Standard", "▁K ,▁S", ".▁All ▁data", ".▁All ▁other", "▁Y es▁or▁no", ".▁I MC-", "\n\nConfidential ity▁", "▁new ▁treatment", "▁new ▁protocol▁amendment", ",▁G re", ",▁G rif", ",▁G iovannucci", "▁investigational▁product ▁administration", "▁about ▁your", "▁has▁been ▁for▁you", "ed▁c ohort", "ing▁a ▁comprehensive▁", "s▁and ▁a", "▁allow s▁", "during▁the▁ first", "▁St art", "-m alate▁", "▁trans mission", "▁review ▁the▁subject’s▁", "▁review ▁of▁the▁data", "s▁at ▁baselin", "s▁at ▁Baseline:", "▁part y▁or", "▁every▁ 4", "within ▁30", "within ▁the▁previous▁", "Con nell", "mad o", "mad e▁by▁", "▁protocol ▁violation", "\n\nG l", "\n\nG CP", "\n\ns hould▁", "\n\ns creening", "▁14 ▁days▁before▁randomization", "▁perform ▁a", "MD AS", "▁Appendix ▁A", "▁ver ify▁the▁", "Un iform", "cer vix", ",▁L eucovorin", ",▁L itin", "randomization ▁factor", "studies ▁to", "▁the▁first ▁PSA", "related▁to ▁the▁study", ",▁p emetrex", "▁cetuximab ▁therapy▁", "upplement ation", "21 00", "diseas e,", "diseas e)", "▁+ 44", "label ed▁per", "e▁a ▁t", "ence▁in ▁a▁patient", "▁IV ▁contrast", "▁IV ▁infused▁", "caus al", "▁Q OL", "▁assign ▁the▁study▁records▁to", "ven ous▁", "▁KRAS ▁status", "▁clinical▁ study", "618 10", "ation▁of▁the▁ trial", "expect ed▁that", "osph or", "▁the▁b evacizumab", ",▁in creas", "▁health ▁benefit", "▁health ▁rating", "at▁least ▁400▁IU", "▁OF ▁EMERGENCY", "▁agre es▁with▁the▁", "new ▁responsible▁person", "\n\nStudy▁ Treatment", "\n\nStudy▁ flow▁chart", "86 G", "1,▁ 8,▁", "IG H", "▁hav e▁to", "▁Treatment ▁Arm▁A", "▁18 95", "HR QOL", "\n\nthe▁ event", "▁and▁s end", "▁October ▁2003", "▁long er▁than", "▁safety▁ review", "▁safety▁ follow-up", "▁safety▁ information", "ology /", "▁ABI-007 /carboplatin", "▁phase▁ 3", "▁subjects▁with out", "refer red▁to▁as▁“", "▁AND ▁QU", "100 ▁x▁109/L", "); ▁", "▁serum ▁PSA", ".\n\n6 .1", "RECIST ▁Criteria", "▁without ▁objective▁", "primary▁ care▁physician", ",▁if ▁b", "contain ed▁in▁the▁", "ing▁ evidence▁of", ".▁L ill", "▁or▁ early▁termination", "▁condition al▁", "bov e▁", "▁Con f", "red ness", "evaluation ▁–▁general", "\n\nt issu", "2- 19", "▁par affin", "▁Patients▁ With", "aw less", ",▁K im", "ier arch", "measure s▁of", "hav e▁shown▁that", "avail ability▁of", "ised▁ Registration/", "cycl e,▁", "\n\nm ▁c▁/", ".\n\n5 .1", ".\n\n5 .2", "Amgen \n\n", "▁Med ical", ".▁G iven", ".▁G rup", "occurr ence▁and▁nature▁of", "elf ▁care", "▁would▁ indicate▁that", ".\n\nIn ▁the▁", "ey el", "▁(se e▁definition▁in▁Section▁4.7.1.1", "▁e▁ c", "▁28 ,▁2008", "▁28 ▁days▁before▁randomization", "agent s▁inter", "pers istent", "▁scor e▁(", "▁investigator ▁assessment", "plann ed▁treatment", "ed▁m ethod▁", "ed▁m anner", ".▁199 4;", "▁only ),▁", "\n\nPro gressive▁Disease▁(PD):", "▁≥ ▁100▁x▁109/L", "▁CTCAE ▁grad", "▁CTCAE ▁Grade▁4", "▁Arm▁A ▁(", "%) ▁had▁", "ren al▁", "ren ch", "requirement s▁for", "▁the▁primary▁ OS", "3- 4", "ates▁ into", ".\n\n7 .1", "▁person ▁responsible▁for▁the▁", "esign ▁and▁Control", "AT ED", "▁schedul ed▁visit", "ocyt es", "cas es▁of", "▁MRI ▁scan", "sit e▁of", "ing▁on e▁(1)", "atch ▁number", "atch ing▁placebo", "ed, ▁the▁investigator", ",▁m ic", "▁Ex clusion", ")▁in ▁patients▁(pts)▁with", "oler ability▁", "▁25 ▁mg/m2", "▁25 ,▁2008", "▁the▁trial .▁The▁", "▁medical ▁practitioner", "▁Grade▁3 -4", "s,▁and ▁agrees▁with▁the▁", "▁but ton", ".▁J▁Clin▁Oncol ▁23", ".▁J▁Clin▁Oncol ▁22", "▁Safety▁ Follow-Up", "▁Safety▁ Officer", ".\n\nB efore▁", "CC 1", "e,▁the▁ end▁of▁study▁is▁", "analyz ed▁", "chest ▁wall", "NCI ]", "▁improv e▁", "▁(or ▁other", ".1.2 ▁Rec", "high ly▁", "high -dose▁", "▁mic rosatellite▁instability", "▁mic roscop", "Ther asse▁et▁al.▁2000", "clinically▁ relevant", "o- gastric▁cancer", "▁a▁l og-rank▁test", ",▁E l", "baseline▁ BMD", "skin ▁toxicity▁", "▁supplement al▁sourc", "resolv ed?", "▁fl uoropyrimidine▁", "infusion ▁reaction", "▁Dose▁ Reduction", "Sponsor ▁Contact", "safety▁ information", "safety▁ follow-up▁visit", "▁experienc es", "▁experienc es▁an", "es▁that ▁have▁their", "▁function al▁", "▁function ▁test", "plus▁ prednisone▁", "................................................................................................................ ......", "▁target ▁volum", ",▁J ud", ",▁J ack", "▁To ▁evaluate▁", "▁Table▁ 1", "de clared▁", "list ed▁in", "ed▁by▁the▁investigator ▁as▁", ".\n\nN ▁A", "▁onc ology", "▁chest ▁wall", "HA SE", "read ▁the▁attach", "sk elet", "▁paclitaxel ▁and▁carboplatin", "evaluated▁ at▁each", "\n\nTable▁ JMHD", "ability▁of ▁all", ".▁At ▁the▁", "▁and▁D is", "▁and▁D ay▁", ".▁5 9", "\n\nCom mon", ".▁Wh er", "▁randomis ation▁to", "(S uppl", ".▁V ial", "activ ated▁", "\n\nW eight", "▁60 ▁mL/min", "\n\nProtocol▁Amendment \n\nPage▁", "s.▁A mgen", "schedul ed▁", "▁and▁d emographic", ",000 /mm3)", "\n\n(cid:120) ▁Percent", "▁Per son", "▁possibl e▁to", ",▁O VER", "EP O", "▁and▁in itial", "e,▁or ▁spinal▁cord▁compression", "cut e▁", "▁of▁10 ▁mM", "▁date▁ for", "▁throm boembolism", ".▁Con firm", ".▁Con current", "▁significance▁level ▁of▁0.025", ",▁patients▁ who", ".\n\n10 .5", "▁with▁a ▁black", "▁the▁primary ▁tumor▁or", "stratifi ed▁by▁the▁randomization", ".▁No ▁significant", "▁ZD4054 ▁or▁placebo", "▁blood▁sampl e▁for", "▁blood▁sampl ing▁and▁handl", "▁Date:▁04 ▁April▁2008", "▁Panitumumab▁Protocol▁Number:▁20050181 ▁Date:▁04▁April▁2008", "▁the▁sampl e▁size▁", "4▁week s▁prior▁to", "▁normal ▁saline▁", "▁qual ity▁", "▁an▁in ability▁to▁determine▁the▁status▁of▁that▁particular▁tumor▁for", "▁path ologist", "procedure s▁or", "objective▁ response▁rate▁", "objective▁ response▁rate▁(ORR", "▁plann ed▁interim", "request ed▁to", "▁add itive▁", "IS H", "s▁ar is", "s▁ar e▁the▁", ".▁Ex ception", "▁men ▁and▁women", "gener ated▁", "▁(T O", "▁Research ▁Addendum", "▁Research ▁and▁Treatment", "hypothes es", "▁IN R", "▁IN -T", "▁IN ▁CASE", "▁regard s▁to", "88 8)", "nausea ▁or▁vomiting", "\n\nU LN", "\n\nU rine▁", "disease▁progression ▁or", "maximum ▁tolerated▁", "▁written ▁statement", "▁vs.▁ 8", "care \n\n", "care fully▁", "▁Ac et", "▁5-FU /FA", "sever ity▁", "sever e▁(", "▁endpoint s▁", "▁statist ician", "5-fluorouracil ▁dose▁level", "uspect ed▁", "▁50% ▁of▁the▁", ",▁un stable▁angina", ".▁Thes e\n\n", "made▁ available▁for", "made▁ only▁with", "necessary ▁to▁provide▁", "\n\n12 .4", "es▁of▁the▁ company,▁", "period▁ from", "(1 ),▁", "▁defin itiv", "▁Tumor ▁Tissu", "▁is▁responsible▁for ▁forward", "s,▁including ▁small▁lesion", "▁laboratory▁ certification", "▁With in", "es) .▁In", ".▁Pro gression", "▁well -t", ".\n\nM EASUREMENTS", "▁the▁interim ▁and▁final", "▁you▁have▁ an", "▁del ays", "▁for▁a ▁duration▁of", "full y▁in", "\n\ni \n\nl\n\na", "recorded▁on▁the▁ eCRF", "hematologic ▁toxicities", "improv ed", "▁anti angiogenic", "\n\nE▁S▁A▁E▁L▁P\n\n.▁T▁N▁E▁M▁U▁C▁O▁D \n\nC▁I▁N▁O▁R▁T▁C▁E▁L▁E\n\nN▁A\n\nF▁O\n\nY▁P▁O▁C\n\nD▁E▁T▁N▁I▁R▁P\n\nA\n\nS▁I\n\nS▁I▁H▁T", "cr ystal", "may ▁also", "▁is▁the▁ most▁common", "▁minutes▁ at", "HC G", "hist ologic", "▁histor y", "▁........................................................................ ...▁", "s▁must ▁also▁be▁", "▁ask s▁about", "\n\nAdd: ▁PART▁B:", "ecut iv", ")▁and ▁then", "at▁a ▁starting▁dose▁of", "censored▁at ▁the▁last", "\n\nThis▁ is▁a", "\n\nThis▁ study▁will▁be▁", "▁rate▁ and▁", "▁inform ing▁the▁", "-T reat", "▁recent ly▁", "▁nam ed▁", "consent▁form ▁should▁be▁provided▁to", ".▁U sing", "s.▁B r", "compared▁to ▁docetaxel", "▁resolv e▁", "▁resolv e▁any▁", "epidermal▁growth▁factor▁receptor ▁(EGFR", "be▁t ermin", "\n\nTh ese▁", "orph ine▁", "▁Require d▁", "▁cycles▁of ▁treatment", "▁2007; ▁9", "changes▁in ▁laboratory▁valu", "▁................................................................ .......▁", "initi ated", "\n\nsubject s▁with", "character istics▁", "▁Protocol▁Amendment s▁and▁Study▁Termination", "▁less▁than ▁1", "\n\nPatient ▁Reported▁Outcom", "▁adjust ing▁for", "immediately▁ life-threatening", "▁third▁ dose▁reduction", "wor ding", "▁some▁ patients▁", "perty▁of▁the▁sanofi-aventis▁group▁-▁strictly▁confidential▁WW-CLIN-PR007-SD-03▁VERSION▁n°02▁(19-DEC-200 5", "ackage▁ Insert", ",▁it ▁is", "▁Non- Small▁Cell▁Lung▁Cancer", "cidence▁ and▁", "▁thromb osis▁", "e.▁In vestigator", "ating▁the▁ confidentiality▁of", "overall▁survival ▁tend", ".▁K M", "starting ▁at", "onc e▁daily▁", "▁1▁week ▁or▁mor", "administration▁of ▁panitumumab", "done▁ at", "▁primary▁ endpoint", "▁Man uscript", "▁Health ▁Study", "▁Gen etic", ".▁Phase▁ I", "spect or", "ed▁dos e,▁", "pleas e▁", "serious▁adverse▁event s▁", "▁frequ ency", "approv ed▁by▁the▁", "flu ence▁", "▁stor ed▁at", "▁non-target▁lesion s▁identified▁at▁baselin", "▁abov e▁the▁", "▁analgesic s,▁", "ession al▁", "▁STUDY ▁P", "▁STUDY ▁PROCEDURES", "observed▁ RR", "Rec ording▁of", "▁ent ry", "▁study▁visit ?", "AMG▁162 ▁in▁the▁Treatment▁of▁Bone▁", "bear ing", "e▁includ ing", "\n\nGrade▁ 1", "Reg ulatory▁", "add ress", ".▁Data ▁Qual", "rest ▁of", "minimum ▁lesion", "minimum ,▁and▁maximum", "▁as▁possibl e▁", "▁response▁rate▁ and▁", "OP UL", "in▁a ▁continuous▁regimen", "▁wer e\n\n", "▁and▁all ▁other▁sites▁of▁disease▁", ".6.1 ▁General▁Approach/", "suppli ed▁in", "▁hr ▁after▁start▁of", "▁on▁Day▁1 ▁of▁each▁cycl", "▁Information ▁and▁Consent", "▁gener ating", "▁NCCTG ▁Addendum", "EA ▁level", "▁identifi er", "▁IC F", "▁prolong ed▁", "▁combin ed▁", ".▁Com plet", "▁lead s▁to", "▁tr ack", "war eness▁of▁the▁", "▁best ▁supportive▁car", "▁concomitant ly▁with", "▁must▁be▁obtain ed▁for▁all", "▁might ▁affect", "▁documented▁ PD", "cop ies▁of", "▁thos e▁that", "area ▁under▁the▁curv", "whichever ▁comes▁first", "▁investigational ▁agent", "confirmed▁ no▁less▁than▁4▁weeks▁after", "controlled▁ Study▁to", "ed▁in▁accordance▁with ▁institutional▁policy", "▁should ▁also▁be▁", "greater▁than ▁or▁equal▁to", "opportun ity▁for", ",▁1 ,▁or▁2", "▁stop ▁the▁", "diagnos is", ",▁in▁the▁ case▁of", "▁port ion▁of", "▁of▁the▁study▁ staff", "handl ing", "▁of▁outcome▁variabl es▁in▁relation▁to", "▁oste oclast", "▁CO M", "▁CO X-", "▁study▁ent ry▁", "yes /no", "opath ological▁", "▁valid ation", "▁valid ated", "▁VEGF ▁inhibitor", "ohist ochemical▁", "▁log istic▁regression▁model", "▁staff )", "▁the▁investigational ▁sit", "s▁per ▁day", "▁deriv ativ", "notification s,▁and▁agrees▁with▁the▁", "▁d▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁PANITUMUMAB▁(AMG▁954)▁Protocol▁Number:▁20040249▁Date:▁07▁August▁2007\n\nPage▁", "▁d▁e▁v▁o▁r▁p▁p▁A\n\nProduct: ▁Panitumumab▁Protocol▁Number:▁20050181▁Date:▁04▁April▁2008\n\nPage▁", "usual ▁activities▁", "Pharmac y▁Guid", "imag es▁", "▁(eg ,▁a", "▁the▁pre par", "80% ▁dose▁level", "purpos e▁of▁the▁", "▁Sunitinib ▁Malate▁", "show ed▁that", "\n\nI▁am ▁able▁to", "ATA ▁MANAGEMENT", "▁........................................ ......", "ont arget▁Lesion", "▁to▁receive▁ either", "▁is▁in advert", "▁guid ance▁", "\n\nSection:▁10 .5", "▁recurrent ▁or", "\n\nArm ▁B", "▁a▁minimum ▁of▁two", "regular ly▁", "▁complaint ▁form", "manufact uring", "▁Suppl ):", "\n\nAdd▁6 \n\nAdd▁6", "recover ed▁to", "▁FACT- L/N", ".\n\nPatients▁ will▁be▁", "dosing ▁regimen", "▁determine▁if ▁denosumab▁is▁", "bumin- bound▁", "30-day▁postdiscontinuation▁follow-up ▁period▁(", "-B ased▁", "9) Toxicity▁", "hold▁ panitumumab", "▁↓ ▁One▁", "▁brain ▁metastases", "▁soft w", "prognostic ▁factor", "▁Days▁ 1-14", ".▁In▁the▁event ▁that", "definition s▁of", "breast -feeding", "clar ification", "▁treatment▁and▁ follow-up", "▁WC ,▁H", "we▁ have▁", ".▁Your ▁doctor▁will", "▁objective▁progression ▁of", "at▁any▁tim e▁and▁", ")\n\n4 .2.1", "▁should▁be▁performed▁ with", "your▁doctor ▁will", "▁2006; ▁8", "▁Qual ity▁of▁Lif", "▁Medical▁ Journal▁", "we ating", "\n\nPre treatment", "▁the▁sub distribution", "▁intern al▁", "▁intern ational", "▁reasons▁other▁than ▁disease▁progression", "itu ation", "▁and▁M eier", "▁rate▁of ▁5%", "▁HR QoL", "▁consult ▁with", "▁samples▁will▁be▁ destroy", "▁observation ▁mad", "extension▁lead▁ period▁", ".D .,▁", "at▁each ▁visit", "▁need l", "▁the▁primary▁endpoint ▁of", "null▁hypothes is", "ity▁in ▁accordance▁with", "▁any▁s ide▁effect", "ed▁by▁an ▁independent", "▁Questionna ires", "questionnair e▁and▁", "▁contains▁ no", "▁cur atively", "▁deviation s▁from", "▁Cl assification", "▁rat es▁of", "indication ▁to", "▁confidence▁interval▁ for▁the▁", "▁fracture▁ or", "Radi otherapy▁", "▁Supplement ),▁", "e.\n\nP atients▁", "partial▁ respons", "partial▁ response▁(PR", "\n\nAdd▁2 ,3", "▁angiogenes is▁", "▁mucos a", "▁will▁be▁compared▁ at▁a▁significance▁level▁of▁5%", "refer▁to▁the▁ current", "▁questionnair e▁that", "/In dependent▁Ethics▁Committee▁(IEC", "▁mov e▁them", "▁Survival▁ Follow-up", "▁ascit es▁or", "▁abdominal ▁masses▁that▁are▁not▁confirmed▁and▁followed▁by▁imaging▁techniqu", "inform ation▁of", "▁to▁in crease▁", "estrogen ▁receptor", "▁age▁ group", "s▁taken ▁in▁combination▁with", "▁all▁subjects▁ have▁", "▁will▁have▁ access▁to", "▁signs▁and▁symptom s▁of", ".▁Ann al", "▁address ▁and", ".▁Un der", "▁Pemetrex ed▁in", "und red▁", "▁or▁its▁design ated▁", "arket ing", "▁subjects▁receiving ▁AMG▁162", ".▁Vitamin▁D ▁intak", "Code: ▁D8480C00013", "final▁ PFS", "▁drop ▁in", "▁ASCO ▁Annual▁Meeting▁Proceeding", "symptomatic ▁deterioration", "International▁Conference▁on▁Harmon isation", "▁of▁study▁ population", "notifi ed▁to", "prescrib ed▁dos", "ared▁ Res", "enrolled▁in ▁the▁study", "objectives▁ –", "E▁R▁O▁F▁E▁B \n\nY▁T▁I▁D▁I▁L▁A▁V", "egr ated▁", "▁Advanced▁ Non-Small▁Cell▁Lung▁Cancer", "▁Complet ed▁", "▁description ▁of▁the▁", ",▁we▁ have▁", "Oral▁Rectal▁ Subcutaneous▁", "▁SU 11248", "▁reserv es▁the▁", "▁study-related▁ record", "▁interval▁ is▁", "▁measurements▁and▁ co-", "▁the▁safety▁follow▁up ▁phas", ".\n\nSTUDY ▁MANAGEMENT", "oprot ection", "vitamin ▁E", "▁Day▁ 8", "achin e▁typ", "▁7▁days▁of ▁each▁radiological", "▁199 3;", "▁anti-panitumumab ▁antibody", "procedures▁for ▁unblinding▁the▁study", "▁regulatory▁author ities", "▁regulatory▁author ities▁", "nod ul", "▁Approv ed▁by▁Lilly:", "ysesthes ia", "▁Fax :▁(", "patient▁reported▁ outcomes▁(PRO", "▁superior ity▁of", "\n\nAppendix▁I ▁Page▁", "\n\nStudy▁Design ▁and▁Treatment▁Schema", "chest,▁abdomen ,▁pelvis", "▁origin ▁in▁the▁D", "ken s▁CH", "▁principl es▁that▁have▁their", "▁bolus▁ given▁over▁2▁to▁4", "▁It alian", "▁poss ibly▁", "▁antibodies▁against ▁panitumumab", "▁antibodies▁against ▁IMC-11F8", "▁ECOG▁performance▁stat us", "\n\nChang es▁to▁the▁protocol", "▁exploratory▁biomarker ▁development", ",▁whichever▁is▁ later", "capture d", "imb urg", "\n\nPer form", "▁a▁small ▁molecul", ".▁Refer ▁to▁the▁", "▁occurred▁ in", "gestive▁heart ▁failure▁", "regulatory▁ag ency▁", "regulatory▁ag ency", "ge ographic▁region", "s▁during ▁treatment", "▁Diseas e", "▁RT K", "romos ome▁", "\n\nStudy ▁agreement", "associ ation▁of", "carcinoma ▁of▁the▁", "hazard▁ ratios", "▁the▁benefit :risk▁profile▁", ",▁strok e,▁and▁", "▁handl ing", "compr ised▁of", "▁LB ,▁Willett▁WC", "▁consequ ences", "▁change▁of ▁femoral▁neck▁BMD", "ockcroft▁and▁Gault ▁1976", "▁etoposid e/cisplatin", "▁subjects▁have▁ access▁to▁commercially▁available▁product▁or▁for▁up▁to▁2▁year", "ummary ▁tabl", "▁confirmation▁of▁ eligibility", ":▁the▁ effects▁of", "▁bal ance▁of", "▁second -line▁", "▁Over view", "▁modifi ed-RECIST", "fficacy▁and▁ pharmacodynamic", ".▁Of ▁the▁", "stored▁for ▁up▁to", "median▁PFS ▁for", "▁AND▁DEFINI TIONS▁OF", "inancial▁Dis closure", "▁compan ies▁", "▁pre-specifi ed▁", "\n\nVisit \n\nVisit", "Schedule▁of ▁Assessment", "measurements▁and▁ variables▁", "▁Radiation ▁Therapy▁", "stea d▁of▁the▁", "▁CYP3A4 ▁inhibitor", "102 23", "▁from▁all ▁supplemental▁sourc", "anna ▁N", "▁sub- population", ".▁Overall ▁survival", "TO I", "▁slice▁thickn ess▁", "▁or▁at ▁hom", "▁First ▁Street", "not▁to ▁participate▁in▁this▁study", "bind ing▁of", "▁leuk openia", "▁peripheral▁neuropath y▁", "▁discontinue▁from ▁study▁treatment", "documented▁in ▁the▁subject’s▁", "ince▁your▁last ▁study▁visit?", "▁twice▁ per", "▁the▁interpret ation▁of▁the▁study▁", "chemistry▁ profil", "epatitis▁ C", "uration▁of▁ response▁(", "ocock ▁SJ", "ance▁in ▁Investigational▁Product", "▁androgen ▁dep", "▁health▁state▁ index▁scor", "▁telephon e,▁and", "\n\nNon-PD /NA**", "inspect or", "▁back ▁to", "es),▁ surgery▁to", "▁rath er▁than", "▁a▁subset ▁of", "95%▁confidence▁interval▁ for▁the▁", "improvement ▁in", "▁At▁least ▁a▁20%▁increase▁in", "▁regulatory▁ag encies▁", ",▁2008;▁Page▁ D", "mas s▁index", "▁the▁appearance▁of ▁one▁or▁more▁new▁lesion", "▁Amended▁ Clinical▁Study▁Protocol", "▁or▁discomfort ▁I▁have▁", "e▁through ▁the▁", "▁BID ▁=", "▁the▁date▁ when", ".▁Dis cussion", "▁CT/MRI ▁scan", ",▁Mor i", "▁discover y▁or", "at▁least▁one▁ on-study▁SRE", "\n\nStatistical▁ evaluation▁–▁general", ",▁Stampfer▁MJ ,▁Colditz▁GA", ",▁24,▁ 36", "ed▁while▁on ▁or▁after", "▁of▁D esign▁and▁Control", "useful ▁in", "avis▁ CD", "▁abs cess", "▁pemetrexed,▁ carboplatin", "lip id", "erson al▁", "▁sensitivity ▁analyses▁of", "▁wash out", "▁compared ▁to▁the▁", "▁investigational▁product▁is▁ re", "▁Formula ▁for", "▁make▁ entries▁and/or", "▁reconstitut ed▁ABI-007", "▁VARIABLES ▁AND▁DEFINITIONS▁OF", "7)\n\n(cid:13 7)\n\n(cid:13", "7)\n\n(cid:13 7)▁(cid:137)▁(cid:13", "at▁any▁ dos", "compl ish", "▁Figure▁ 1", "▁H3E-MC-JM IG", "▁throughout▁the▁ entir", "▁(Table▁ 1)", "regional▁ lymph▁node▁is▁N0", "ltras ound▁", "Dx S", "Path ology▁", "sur rounded▁by▁aerated▁lung", "ened iamin", "▁an▁SRE ▁by▁", "endothel ial▁cell", "s.▁Ther eafter", "he/sh e▁must", "\n\nM0 ▁M0", "\n\nMethod▁of ▁assigning", "▁intramuscular ▁injection", "▁Non-PD ▁Non-PD", "▁IV▁infusion▁in ▁500▁mL", "arnofsky▁ Scor", "▁anxious▁or▁depress ed▁I▁am", "▁we▁will ▁have▁", "uppress ive▁", "medicin al▁product", "FACT-Fatigu e▁subscale▁scor", "▁alone▁as \n\n", "▁will▁be▁used▁to▁compare▁treatment s▁with▁respect▁to▁both", "J,▁K aplan", "Over dose▁", "facil ities", "▁esophag itis▁", "▁tast e▁in", "unn ▁PA", "ed▁both ▁individ", "▁the▁investigational▁ study▁sit", "rosome▁ amplification", ")(cid:10 )(cid:", "▁+/- ▁C225", "reported▁to▁Amgen ▁within▁1▁working▁day▁of", "▁glutam ic", "\n\nProgression-free▁s urvival▁(PFS", "\n\nDescription▁of ▁analysis▁set", "informed▁of ▁all", "e▁involv ement", "▁intellect ual", "Under going", "where▁appropri ate", "delayed▁for ▁up▁to", "e▁on▁a ▁variable▁", "▁fever▁or ▁infection", "▁archival ▁tumour", "Therapy▁During▁Study▁ Period", "▁apparent ▁discrepanc", "inflammatory▁ drug", "▁tired ness", "▁cardi oprotection", "urb anc", "▁Calculated▁ Creatinine▁Clear", "▁Product ▁Characteristic", "▁Sh ared▁Res", "▁TNM ▁Staging▁System▁for▁Lung▁Cancer", "advis ed▁to", "athyroid▁ hormone▁", ".▁Determination▁of ▁Sample▁Size▁", "▁non-mut ated▁(", "more▁frequ ent", "▁risk▁reduction .▁For", "procedures▁and▁ data.▁Direct", "keletal▁surv eys", "light▁h ousework", ".▁Respon dent", "ematology▁panel: ▁CBC", "duration▁of▁response▁( DOR", "▁corresponds▁to ▁ECOG", "▁reasonable▁possibility▁that▁the▁event▁may▁have▁been▁caused▁by \n\ninvestigational▁product", "▁always▁be▁ ask", "idiarr heal", "DM SC", "covari ate▁", "▁loper amide▁", "’s▁b rochure", ".▁Disease▁ progression", ".▁Reg ulatory▁", "▁occurs▁prior▁to ▁disease▁progression", "70▁and▁ older", "▁NCI- CTCAE", "▁qualify ing▁for", "▁Planned▁Methods▁of ▁Analysis▁", "drawn▁from ▁each▁patient", "emperature ,▁blood▁pressure,▁", "▁adequately ▁treat", "▁Previously▁Un treated▁Metastatic▁Colorectal▁Cancer", "orrections▁to ▁electronic", "/0 ,", "surgical▁ resection", "▁manufact urer", "again st", "▁must▁submit ▁and", "echt ▁JR", "▁an▁option ▁to", "herein after", "increase▁the▁ risk▁of", "▁before▁study▁ initiation", "▁known▁to▁have▁ di", "every▁6▁weeks,▁ ±▁1▁week", "examining ,▁analyz", "publication▁or ▁presentation", "ed▁in▁the▁Study▁Plan ,▁Table▁", "hort▁Form▁( BPI-SF", "oftware ’s▁“audit▁trail", "▁time▁from▁randomization▁date▁to ▁date▁of", "how▁good▁or▁b ad▁", "dail y▁supplement", "mechanism▁of▁action ▁of▁necitumumab", "▁true▁ each▁statement", "▁safety▁and▁efficacy▁ data", "ulum ▁vita", "▁should▁be▁retain ed▁in▁accordance▁with▁institutional▁policy", "▁disease▁progression▁should▁be▁ evaluated▁for", "▁level▁in▁the▁ blood;", ",▁Ar mitage▁", "▁coronary▁ heart", "pain▁severity ▁and▁", "vitamin▁D▁supplement s,▁", "▁days▁prior▁to▁C1 D1", "\n\nEthical ▁conduct▁of▁the▁study", "circl ing▁one▁(1)", "▁cervical ▁cancer", ",▁Heaney▁RP ,▁Holick▁MF", "▁is▁obligated▁to ▁inform", "\n\nRestricted▁in▁physically▁strenuous▁activity▁but ▁ambulatory▁and▁able▁to▁carry▁out▁work▁of▁a▁light▁or▁sedentary▁nature,▁", "aenoic▁acid▁ [", "oppos ed▁to", "▁Method s▁for", "ine▁is▁ marked▁", "ultin ational", "\n\nTest ▁result", "i-dimension ally▁measurable▁lesion", "Analyt ical▁Plan", "▁occurs▁at ▁or▁near", "substitut ed▁for", ",▁Gar land▁", "▁Febrile▁ Neutropenia", "describes▁the▁ conduct▁and▁results▁of", "▁OF▁STUDY ▁VARIABLES▁AND▁DEFINITIONS▁OF", ".\n\nInt roduction", "\n\nVolume▁of ▁blood▁sampling▁and▁handl", "▁medical▁problem s▁s", "▁and▁institution ▁permit", "best▁supportive▁car e▁(", "▁Evaluate▁ AMG▁162▁in▁the▁Treatment▁of▁Bone▁", "analysis▁will▁be▁censored▁using▁the▁last▁available▁ assessment▁date.\n\n", "▁transient▁is chemic▁attack", "residual▁ lesion", "pG▁island▁ methyl", "▁Practice▁Guidelin es▁and▁Technical▁Standard", "▁MEDIC INAL▁PRODUCT", "▁evaluate▁time▁to ▁response▁and▁", "s▁with▁performing▁my▁ usual▁activities▁", "▁earli er▁than", "elz ack", "rauterine▁ devic", "e,▁pleas e▁indicate▁how", "leeland▁ CS", "▁gene▁c opy▁number", "▁at▁least▁25% ▁for▁a▁duration▁of", "▁mL▁of▁0 .9%▁Sodium▁Chloride▁Injection", "Evaluable▁ Analysis▁Set", ".▁These▁signature s▁will", "▁fracture▁( vertebral▁", "Response▁(PR ):", "▁SYST EM", "▁Epidemiology,▁ Biomarker", "▁ever▁comes▁first .▁If", "anton io", "▁600▁mg/m2 ▁IV▁infusion▁in▁500▁mL", "ultim ately▁", ",▁Holl is▁BW", "Printed▁copy▁is▁not▁official▁record .\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁Panitumumab▁Protocol▁Number:▁20050203▁Date:▁21▁January▁2009\n\nPage▁", "ing▁any▁record s▁and▁report", "▁and▁an▁IV▁infusion ▁of▁zoledronic▁acid▁", "goals▁for ▁the▁target", "▁400▁mg/m2▁IV ▁bolus▁given▁over▁2▁to▁4", "/favorable▁ opinion", "Committee▁of ▁Medical▁Journal▁", "▁blood▁pressure,▁resting▁pulse,▁ respiration▁rate,▁and", "recorded▁and▁measured▁ at▁baselin", "s,▁Subsets,▁and▁ C", "istence▁of▁one▁or▁more▁ non-target▁lesion", "▁Biomedical▁ Journal", "▁w▁±3▁d▁after ▁Day▁1", "OME ▁VARIABLES", "os▁A P", "isl ation", "▁wit ness", "▁1.▁O BJECTIVES▁........................................................................................................", "agaz in", "\n\nAudit s▁and▁inspection", "▁NUMB ER", "▁confidential▁ information", "eventh ▁Edition", "▁on▁which ▁they▁are▁", "\n\nDetermination▁of ▁sample▁siz", "equisition ▁Form", "ABO RATORY", ",▁Henne kens▁CH", "▁radioisotop es),▁surgery▁to", "s▁of▁the▁question :", "289] ,▁1997", ",▁Gord on▁D", "▁during▁the▁past ▁7▁days", "best▁of▁his▁or▁her ▁knowledge,▁the▁report▁accurately▁", "used.▁C orrections▁to▁electronic", "▁child- bearing▁p", "otherwise▁indic ated", "▁item▁of▁the▁ Brief▁Pain▁Inventory▁(BP", ".▁Sample▁Size▁and▁ Statistical▁Method", "▁OR▁P REGNANCY", "▁and▁Human ▁Servic", "▁and▁MRI▁are▁the▁best▁currently▁available▁ and▁", "▁global▁deterioration▁of ▁health▁status▁requiring", "\n\nNot▁at▁all\n\nA▁little▁bit\n\nSome-▁what \n\nQuite▁a▁bit\n\nVery▁much", "ensive▁treatment▁in▁an▁emergency▁room ▁or▁at▁hom", "(serum ▁sample,▁", "Dock et▁No.▁", "DOSE ▁OR▁PREGNANCY", "Randomisation ▁C", "onatal ▁death", "▁to▁Informed▁Consent▁Form ▁for", "estra must", "▁OUTC OME▁VARIABLES", "all▁Street ▁Journal", "efract ory▁", "▁are▁cons uming", ",▁and▁reproduc ing▁any▁records▁and▁report", "▁BEN EFI", "▁state▁you ▁can▁imag", ".▁Simopoul os▁AP", "▁timetable▁and▁ end▁of▁study", "suffic i", "rial▁fib rill", "defined▁and▁ surrounded▁by▁aerated▁lung", "linding▁and▁ procedures▁for▁unblinding▁the▁study", "atistical▁and▁ Analytical▁Plan", "arrhyth mic", "▁number▁per▁lin e,▁please▁indicate▁how", "lesions▁will▁only▁be▁ considered▁measurable▁when▁they▁are▁superficial▁", "▁new▁protocol▁amendment ▁would▁be▁", "▁has▁been▁for▁you ▁during▁the▁past▁7▁days", "-malate▁ salt", "▁review▁the▁subject’s▁ original", "▁party▁or ▁move▁them", "MDAS I-GI", "Uniform ▁Requirement", ",▁Litin ▁LB,▁Willett▁WC", "▁OF▁EMERGENCY ,▁OVER", "▁1895 ▁525", "▁without▁objective▁ evidence▁of▁disease▁progression", "▁or▁early▁termination ▁and▁send", "ised▁Registration/ Randomisation▁C", "\n\nm▁c▁/ ▁g", ".▁Grup po", "agents▁inter act", "e,▁the▁end▁of▁study▁is▁ defined▁as▁4▁week", ".1.2▁Rec ording▁of", "baseline▁BMD ▁valu", "read▁the▁attach ed▁protocol", "▁Research▁Addendum ▁to▁Informed▁Consent▁Form▁for", "▁Research▁and▁Treatment ▁of▁Cancer", "▁IN-T EXT", "▁IN▁CASE ▁OF▁EMERGENCY,▁OVER", ".\n\nMEASUREMENTS ▁OF▁STUDY▁VARIABLES▁AND▁DEFINITIONS▁OF", "▁asks▁about ▁your", "ating▁the▁confidentiality▁of ▁the▁subject", ".▁Data▁Qual ity▁Assur", "▁of▁outcome▁variables▁in▁relation▁to ▁objectives▁and▁", "notifications,▁and▁agrees▁with▁the▁ content", "9)Toxicity▁ resolved?", "▁↓▁One▁ 5-fluorouracil▁dose▁level", "▁observation▁mad e▁on▁a▁variable▁", "▁origin▁in▁the▁D eclaration▁of▁Helsinki", "▁principles▁that▁have▁their ▁origin▁in▁the▁Declaration▁of▁Helsinki", "▁from▁all▁supplemental▁sourc es▁combin", "▁the▁interpretation▁of▁the▁study▁ result", ".▁Discussion ▁of▁Design▁and▁Control", "\n\nStatistical▁evaluation▁–▁general ▁aspect", "oftware’s▁“audit▁trail ”", "▁true▁each▁statement ▁has▁been▁for▁you▁during▁the▁past▁7▁days", "circling▁one▁(1) ▁number▁per▁line,▁please▁indicate▁how", "▁occurs▁at▁or▁near ▁the▁end▁of▁the▁", "\n\nVolume▁of▁blood▁sampling▁and▁handl ing▁of▁biological▁samples", "▁Evaluate▁AMG▁162▁in▁the▁Treatment▁of▁Bone▁ Loss▁in", "▁at▁least▁25%▁for▁a▁duration▁of ▁1▁week▁or▁mor", "Committee▁of▁Medical▁Journal▁ Editor", "Docket▁No.▁ 86G", "▁state▁you▁can▁imag ine▁is▁marked▁", "▁IN▁CASE▁OF▁EMERGENCY,▁OVER DOSE▁OR▁PREGNANCY", ".\n\nMEASUREMENTS▁OF▁STUDY▁VARIABLES▁AND▁DEFINITIONS▁OF ▁OUTCOME▁VARIABLES", "circling▁one▁(1)▁number▁per▁line,▁please▁indicate▁how ▁true▁each▁statement▁has▁been▁for▁you▁during▁the▁past▁7▁days", "% )\n\n", "( 20", "( 24", "( 28", "( including▁the▁", "( a)", ") \n\nP", ") ▁N", ") .▁E", ") .▁C", ") ▁visit", ") ▁until", ") ▁document", ") .▁Patients▁", ") ▁for▁the▁", ") ▁were▁", ") ▁is▁not", ", ▁ag", ", ▁the▁subject’s▁", "- -", "- J", "- 54", "- 13", "- 80", "- 70", "- Ntx", "- profit", ". G", ". pdf", "/ 5", "/ Ph", "/ paclitaxel", "/ vital▁sign", "/ discomfort", "/ ethnic", "/ independent▁ethics▁committe", "0 .", "0 .1", "1 19", "2 1-Day▁Cycl", "3 5%", "3 ▁days)", "5 ▁mg", "6 -month", "6 ▁plann", "9 2:", "9 00▁mg", "9 ▁weeks▁until", ": ▁R", ": 12", ": ▁J", ": 28", ": \n\n(", ": ▁a▁m", "; ▁S", "; ▁M", "; ▁L", "; ▁NCI", "= ▁0", "> ▁1", "B ▁receptor", "B ased▁on", "C or", "C OG", "C SI", "D LT", "D 8480C000", "E scal", "E toposid", "E uroQol▁Group", "F ig", "F ax", "F ood▁and▁Drug▁Administration", "H u", "H igh", "I A", "I gG", "L ,▁L", "M in", "M easures▁", "O r", "O US", "O MP", "O ’Brien", "O ’Brien-Fleming", "P 3", "Q LQ-C30", "R ang", "R efer", "R atio", "R etention", "S /", "S R", "S h", "S PARC", "T issu", "T ▁cell", "T aken", "U LE", "V 5", "Z ED", "] ▁or", "] ),▁", "a um", "a qu", "a utomatically▁", "a ive▁patients▁with", "b le", "c opy▁of", "c ovariates▁", "c osmetic", "d res", "d ominal", "e .▁Th", "e .▁In▁addition", "f avor", "f ish▁oil", "f utility", "g /", "g astric", "g iving", "h ang", "h olid", "h is/her", "h ospital▁", "i R", "i ere▁", "i e▁C", "j aw", "k idney▁", "k ilogram", "l ed▁to", "l uorouracil", "l ess▁s", "l ess▁of▁the▁", "m e", "m s", "m agnesium", "m alignant", "m argin", "o il", "p in", "p ag", "p reliminary▁", "r w", "r end", "s '", "s eek", "s ix", "s pr", "s ▁abnormal", "s olid▁tumor", "s pontane", "s ▁available▁to", "s ummary▁statistic", "t een", "t ry▁", "u d▁", "u ite▁", "v ast", "w est", "w ish", "w atchful▁wait", "ï v", "’ t", "’ s▁a", "” ▁on", "≥ 1/", "▁ escal", "▁ effusion", "▁ optional", "▁ ..........................................................", "▁ estrogen", "▁ routin", "▁ .▁0", "e▁ collection", "e▁ cetuximab", "in ear", "in ▁other", "in jection", "in eer", "▁t ▁n", "▁t rastuzumab", "at im", "at omic", "on a", "on ad", "\n\n “", "\n\n im", "\n\n study", "\n\n as▁", "\n\n report", "\n\n 54", "\n\n 80", "\n\n may▁be▁", "\n\n inter", "\n\n group", "\n\n have▁been", "\n\n US", "\n\n contact", "\n\n interval", "▁a ▁clinical", "▁a ▁local", "▁a utomatically▁", "▁a ▁docetaxel-based▁chemotherapy▁regimen", "en ▁S", "en ▁E", "er l", "er ▁C", "er ▁J", "er man", "er cul", "or ▁S", "or ▁may▁not", "........ ......", "s▁ =", "s▁ 10", "s▁ observed▁in", "s▁ ......................................................................................................", "s▁ Sub", "s▁ would▁be▁", "re duct", "re striction", "al o", "al one▁", "al ities", "st and▁", "ion ▁of▁", "ent al▁", "it e", "it ation", "it one", "it idine▁", "▁the▁ n", "▁the▁ ‘", "▁the▁ consent", "▁the▁ effects▁of", "an ▁American", ",▁ 5", ",▁ Study▁", ",▁ chemotherapy▁", ",▁ has▁been", ",▁ ie,▁", ",▁ 5-fluorouracil", ",▁ 56", ",▁ see▁Section", ",▁ consent▁form", ",▁ on▁a", ",▁ headache,▁", ",▁ laboratories", "ro vers", "ro ubl", "ed▁ during▁the▁study", "ed▁ visually▁for", "▁an g", "▁an gi", "▁an alyt", "▁an ▁IVRS", "ic c", "ic z", ".▁ 21", ".▁ 29", ".▁ 39", "ll um", "ar p", "ar in-", "ed ▁all", "ed ing▁and▁", "ed ▁time▁point", "▁p ackaging", "▁p ages▁", "▁p mab", "▁p igment", "▁p iecew", "▁c rit", "▁c red", "▁c oagulation", "▁c atheter", "▁b u", "▁b eg", "▁b ecause▁", "▁b rief", "es is", "es .▁All", "es ▁associated▁with", "es ▁as▁an", "for ▁the▁difference▁in", "et o", "et ect", "et ium", "ation ▁in▁the▁", "▁to ol", "▁to ▁com", "▁to ▁disease▁progression", "▁to ▁review", "▁to gether", "▁to ▁indicate▁", "▁to ▁Lilly▁or▁its▁designee▁via", "is pan", "▁s af", "▁s ett", "▁s elf", "▁s epar", "▁s ince▁", "▁s leep", "as e,▁", "as s▁s", "as e;", "▁of ▁E", "▁of ▁their", "▁of ▁Ch", "▁of ▁cediranib", "▁of ▁chest", "▁of ▁DNA", "▁of ▁childbearing▁potential▁", "ou ch", "▁d ate▁in", "▁d epending▁on", "th rough", "▁w ild-typ", "▁m ethod▁of", "▁m ouse▁", "▁m ild▁", "▁m axim", "▁and▁ one▁", "▁and▁ 30", "▁and▁ including", "▁and▁ III", "▁and▁ chemotherapy▁", "▁and▁ stor", "▁and▁ 49", "▁and▁ maximum", "▁and▁ does▁not", "▁and▁ evaluate▁", ".\n\n g", ".\n\n 30", ".\n\n 35", ".\n\n Grade▁4", "al▁ lymph▁nod", "al▁ Anti-", "el i", "el ic", "ab s", "ab sent", "▁A M", "▁A P", "▁A greement", "▁A re▁", "▁A SSURA", "iv otal▁", "▁in -", "▁in ▁Cancer", "▁in ▁both", "▁in ▁bone▁", "▁in ▁men▁with", "▁in fluenc", "................................ ...▁", "ur a", "ur se", "ur ation▁for", "ev ening", "ev ice▁", "ig uration", "00 000", "oc c", "pl astin", "▁1 ▁to", "▁1 .2.3", "▁C OLL", "ac y", "ac e▁", "ac quisition▁of", "es▁ specifi", "es▁ should▁not▁be▁", "▁P I", "▁P ET", "pro hibit", "pro lifer", "▁( 8", "▁( X", "▁( as", "▁( radi", "▁( 14", "▁( SCLC", "▁( such▁as▁", "▁( defined▁as▁", "▁( VEGFR", "▁( CTC", "▁( e.g.", "▁( OPG", "▁( x▁109/L", "em zar", "▁2 )", "▁2 25", "▁2 .2.5", "ul ▁S", "ul ates", "ra ine▁", "if ▁necessary", "if ▁appropriate", "▁S quamous▁", "▁S ummary▁", "▁S ymptomatic", "▁S olid▁Tumor", "▁S equential▁", "▁I RC", "▁re produc", "ag gregate▁", "un controll", "un acceptable▁toxicity", "▁D 1", "▁D etail", "▁D LT", "▁D extros", "cl ass▁", "▁h ospital▁", "▁h eav", "e▁of ten", "e▁of ▁Administration", "▁E d", "▁E ,▁B", "▁E conomic", "am ol", "am oxifen", "ch n", "ch ron", "ch air", "ch emotherapeutic", "▁or ▁v", "▁or ally", "▁or ▁lung", "▁or ▁FOLFOX", "▁or ▁EC", "▁or ▁CT▁scan", "▁or ▁pharmacist", "e▁t axan", "ir d▁", "ut ophag", "ut ies.▁All", "form at", "form ed", "form ed▁to", "form s/", "\n\nP ublication", "\n\nP lease▁", "iz ation▁of", "iz e▁discover", "ex ual▁", "qu ery▁", "▁n M", "▁n or▁other", "▁n umer", "od y▁surface▁area", "ate▁ and", "ate▁ with▁the▁", "study▁ subject", "study▁ data", "study▁ population", "study▁ participation", "lin e▁or", "▁and ▁time▁to", "▁and ▁as▁needed", "abl e,", "▁pro xim", "▁pro state▁", "▁pro portion", "▁pro mpt", "▁T 1", "▁T 3", "▁T H", "▁T S", "▁T wo", "▁T ype▁", "▁T IS", "▁T ABLES", "▁T elephone:", "▁ad en", "▁ad olescent", "▁N either", "▁ar tic", "▁for ▁additional", "▁for ▁use▁in", "▁for ▁collection▁of", "▁for ▁Injection", "▁for ▁Research▁and▁Treatment▁of▁Cancer", "▁for -profit", "▁R ep", "▁R IS", "e\n\n 3", "e\n\n F", "e\n\n If", "e\n\n Study▁", "e\n\n KRAS", "rom at", "▁treatment ▁due▁to", "av ies▁", "▁with ▁no", "▁with ▁either", "▁with ▁non-mutated▁(", "e▁to ▁perform", "e▁to ▁determine▁if", "ed▁b est", "s▁of ▁s", "s▁of ▁the▁study▁", "In ▁addition", "be▁ maintained", "ad e▁J", "ant igen", "\n\nS chedul", "\n\nS evere▁", "▁that ▁time▁point", "▁that ▁you▁have▁", "▁that ▁provides", "▁is▁ complet", "▁is▁ delay", "▁is▁ less▁than", "▁of▁ oxaliplatin", "................................................................ .....▁", "▁will▁be▁ repeated▁", "▁will▁be▁ done▁", "▁will▁be▁ included▁in", "▁will▁be▁ sent▁to", "▁will▁be▁ summaris", "e▁s chedul", "▁M E", "▁M ,▁C", "▁M ,▁G", "▁M ,▁D", "▁M ethod▁of", "▁r ▁o", "▁0 ▁to", "▁0 \n\n1", "▁3 ▁4", "▁3 75", "▁con struct", "▁con stipation", "▁con vulsion", "▁con gestive▁heart▁failure", "event -free▁rates▁", "▁of▁the▁ correction", "e,▁ S", "▁o ▁i", "▁com pos", "▁F act", "▁F ever", "▁F atigu", "▁F OLLOW", ".▁A ▁hazard▁ratio", ".▁A BX-EGF", ".▁A PPENDICES", ".▁The▁ number▁of", "ity▁ will▁be▁", "ity▁ Assessment", "▁g raph", "▁g ram", "not ▁related▁to", "▁the▁s olution", "▁the▁s afety▁and▁", ",▁and▁ subject", ",▁and▁ 24", ",▁and▁ vital▁sign", "ated▁ plac", "▁v eh", "▁v 4.0", "▁L ow", "iseas e", "▁B L", "▁B efore▁", "▁B one▁scan", "▁this▁ with", "s,▁ C", "s,▁ it", "s,▁ will▁be▁", "s,▁ should▁be▁", "s,▁ laboratory", "s,▁ MRI", "s,▁ etc", "s,▁ so▁that", "▁all ▁patient", "▁all ▁patients", "clud es▁", "clud e▁the▁s", "12 .3", "ip unct", "\n\nC entral▁", "\n\nC oagulation", "▁will ▁include:", "▁will ▁serve▁as", "▁will ▁the▁confidentiality▁of", "e▁in vestigator", "e▁in ▁combination▁with", "e▁in struction", "e▁in itial", "ing▁the▁ articl", "▁5 FU", "▁5 ▁dimension", "bo plastin", "ity ▁and", "will \n\nbe▁", "will ▁be", "▁6 7", "▁6 8", "▁6 :", "from ▁randomisation", "▁H ave▁you", "and▁ survival", "▁subject \n\n", "▁subject s,", "▁subject s’", "▁patients▁ should▁be▁", "▁4 .9", ")\n\n (", ")\n\n In", ")\n\n Un", ")\n\n For", "gression ▁models▁and▁", "▁at tain", "▁at ▁start▁of", "ail ed▁", "s▁( for", "s▁( CRF", "s▁( e.g.▁", "s▁( see▁section", "eg en", "▁study▁ guid", "▁study▁ initiation", "\n\n1 .", "\n\n1 .3", "\n\n1 .0", "\n\n1 .\n\nB", "\n\n1 .\n\n2", "ase▁ 2", "vi ously▁", "gen es", "s.▁ V", "s.▁ Cancer", "s.▁ Disease▁", "▁week s▁(", "▁week s▁for", "ens on", "rel ating▁to", "▁any▁ form", "▁any▁ subsequent", "▁V alu", "▁V entricular", "▁V ersus▁", "▁ex cess▁of", "▁ex pedited▁reporting", "ell er", "ak e▁", "\n\nD MC", "\n\nD uring", "\n\nD ay\n\nMonth\n\nYear", "formed▁ decision", "urv ey▁", "▁after ▁the▁end▁of", "▁after ▁paclitaxel", "▁after ▁your▁last", "eth ic", "ed▁for ▁this▁", "s▁and▁ preferred▁term", "s▁and▁ p-valu", "s▁and▁ investigative▁", "ath ologic", "ly ▁as▁possible▁", ".▁S ci", ".▁S ummary▁of", ".▁S UBJECT", "▁patient s.▁In", "▁the▁d enosumab", "s▁will▁be▁ includ", "s▁will▁be▁ the▁", "s▁will▁be▁ determin", "s▁will▁be▁ taken", "ies▁ or▁in", "▁G D", "▁G y▁", "▁G y▁in", "▁G astrointestinal▁", "▁un scheduled▁visit", "report ed▁according▁to▁the▁", "▁e .g", "▁J J", "e▁the▁ error", "▁tim e▁in", ".▁P rospective▁", "\n\nE vent", "\n\nE nd", "\n\nE ndpoint", "\n\nE GFR", "\n\nE nrollment", "▁In itial", "),▁ radiation▁therapy▁to▁bone▁", "▁ant idiarrheal", "s\n\n 2", "s\n\n 5", "s\n\n Y▁T▁I▁D▁I▁L▁A▁V", "ed▁by▁ Consolidation", "▁is ▁a▁c", "▁is ▁a▁m", "▁is ▁abnormal", "▁is ▁able▁to", "▁is ▁the▁purpose▁of", ".▁Th e▁trial", "▁not ic", "▁not ation", "▁not ▁be\n\n", "▁not ▁associated▁with", "EN SATION", "▁may▁ result▁in", "s▁for ▁the▁first", "ial▁ TE", "▁7 .2.1", "▁7 ▁days▁before▁randomization", "▁month s.\n\n", "▁dos e", "▁dos e.▁If", "ich otom", "effect s▁(", "effect ▁was▁", "ocument ation▁and▁", "CT ▁of▁the▁", "▁study ▁assessments▁", "▁per ▁the▁modified▁RECIST▁criteria", "str ont", "s) .▁For", ".6 9", "50 ,000", ".▁E l", "▁assessment s", "▁assessment s,▁", "▁assessment ▁must▁be▁", "▁ag e▁and▁", "▁test s▁of", "▁test ing▁and▁", "are as", "ated ▁according▁to", "ated ▁tablet", "▁ph one▁", "s.\n\n Page▁", ",▁and ▁then", ",▁and ▁applicable▁", "▁sign ed▁", "▁sign ed▁and▁dated▁", "RI OR", "▁Date: ▁<>", "who ▁in", "▁ab st", "te chn", ".▁T el:▁+", "ed▁with ▁the▁study", "’s▁ discretion", "20 ▁mm▁with▁conventional▁techniques▁or", "ed▁at ▁the▁discretion▁of▁the▁investigator", "radi ation,▁", "25 ▁mg", "ian o", "kin e-", "kin d▁of", "▁9 .5", "▁9 .7", "▁9 13", "emet ics▁", "▁8 2", "s▁s pecific", "▁us e▁in▁the▁", "ight Cycl", "\n\nN 0", "\n\nN CI", "cal e▁(", "cal cit", "pre mix", "▁data ▁will▁not▁be▁", "every▁ 14", "every▁ effort", "▁trial s▁of", ").\n\n [", "▁should▁be▁ report", "▁should▁be▁ performed▁in", "____ ___", "▁other ▁studies▁", "ne o", "ne utropenic", "\n\nR ECIST", "\n\nR eview", "17 ]", "subject ’s▁", "▁your ▁future▁", "▁your ▁rights▁as▁a", "▁- 2", "ed▁as▁ “", "24 ▁and▁", "24 -3", "▁Study▁ Monitoring▁and▁Data▁Collection", "▁Study▁ Code:▁D8480C00013", "▁you ▁will", "▁you ▁directly▁or▁to▁alter", "▁a▁s light", "▁the▁study \n\ns", "\n\nF DA", "▁cycl es,▁", "present ing▁with", "present ations,▁", "\n\nT 2", "\n\nT umour", "\n\nT otal", "\n\n3 4", "\n\n3 .6", "\n\n3 .8", "000 ▁mg/m2", "▁im port", "▁im ▁=", "On e▁", "sh ared", "▁the▁patient s’", "ed,▁ label", "dra in", "▁The▁ first", "▁the▁l at", "no ▁further", "▁dose▁ group", "▁inter active▁voice▁response▁system", "▁than ▁on▁placebo", ".\n\nA PPENDICES", "\n\n4 4", "\n\n4 .8", ".▁F rom", ".▁F inally,▁", "▁day s▁for", "le av", ".\n\nP rior▁to", "e▁b eginning", "s▁to ▁detect", "s▁to ▁measur", "s▁to ▁determine▁whether", "s▁that ▁were▁", "s▁that ▁result▁from▁this▁research.▁Neither▁Amgen", "\n\nI NT", "\n\nI t▁is▁", "▁panitumumab \n\n", "▁panitumumab -related▁", "▁panitumumab ▁monotherapy▁", "hy pert", "defin ed▁to▁be▁", "yst eine▁", "▁patients▁with ▁ED-SCLC", "car bam", "/or al", "▁was▁ shown", "fl ak", "fl uid", "▁Version ▁No:", "▁Version ▁Date:▁<>", "▁min imal", "▁min ▁after▁start▁of", "▁death ▁due▁to", ")▁ /", "main ▁bronch", "main ▁study▁is▁", "must▁be▁ reported▁to", "▁Th orac", "uppl y▁and▁", "199 4;", "▁30 ▁days▁", "An n", "SC ▁injection", "▁progression ▁is▁", "▁progression ▁or▁death", "▁evalu able▁for", "e▁and▁ cisplatin", "provid ed▁", "prior▁to ▁dosing", "sign ature", "▁di hyd", "▁the▁study▁ or", "▁the▁study▁ design", "▁includ ed▁", "▁must▁be▁ submitted▁to▁the▁", "▁sampl e▁d", "ru v", "ru it", "▁infusion ▁(", "ox in", "perform ed.\n\n", "ely :", ",▁a ▁commercial▁pharmaceutical▁product", ",▁a pplicable▁", "you ▁will", "until ▁study▁completion", "receiv ed▁s", "ann ock", "ann itol", "ed▁from ▁light", "▁cell s▁", "consider ing▁the▁", "\n\nH epatic", "discontinu ing", "discontinu ed▁due▁to", "ed.\n\n For", "▁treat ed▁for", "▁treat ▁based▁on", "St age▁", "▁sub cutane", "▁sub cutaneous▁", "▁et▁al ▁2005", "OR E", "duc ci", "▁mod ify", "es▁will▁be▁ assign", ".▁B efore▁", "eb rid", "▁analysis \n\n", "▁and/or ▁panitumumab", "▁and/or ▁recurrent", "▁Panitumumab ▁Investigator’s▁Brochure▁for▁further▁detail", "ed▁s ince▁the▁", "ed▁s hould▁not", "collect ed▁in▁the▁", "▁= ▁moder", "▁= ▁mild", "\n\n6 .", "▁report ing▁s", "▁provid es▁the▁", "▁should▁ includ", "▁should▁ call", ",▁s hould▁", ",▁s afety▁", ",▁s urvival", "▁these▁ patient", "▁these▁ result", "▁these▁ cas", "▁these▁ monitoring▁visit", "atist ician", "s▁b eyond▁", ",▁M onth", ",▁M RI", "\n\n7 .\n\nSTUDY▁MANAGEMENT", "▁may▁be▁ develop", ".▁H istory▁of", "▁mor e▁f", ".2.1 .3", ".2.1 ▁Methods▁of▁assessment", "▁clinical \n\n", "▁drug -related▁", "▁drug ▁depend", "week ▁9", "▁dur ing▁and▁", "▁survival ▁benefit", "▁must ▁remain", ",▁C ont", ",▁C rawford▁", "observ ed▁for", "▁blood▁ or", "▁blood▁ draw", "▁blood▁ product", "▁result s▁", "non- measurable▁lesion", "ation▁of▁ study▁treatment", "\n\nIn ▁the▁", "\n\nIn duction", ",▁b aseline▁", "▁19 87", "▁19 90", "▁activ ely▁", "▁gen es▁in", "........................................................................................ ...▁", "Ad dendum", "e▁m ay", "e▁m arker", "\n\nB NP", "thor ax", "es▁( ie,▁", "\n\nM or", "\n\nM etastatic", "\n\nM aximum", "able▁to ▁receive▁", "▁administer ed▁once▁", "▁information ▁for", "set ▁at", "set ▁forth", "▁receiv es", "▁receiv ing▁the▁", "▁receiv ing▁", "▁[ 1]", "end▁of ▁trial", "▁to▁ enter", "part ▁of▁your", "ull ick", "uthor ized▁s", "e▁or ▁h", "e▁or ▁all▁of▁the▁", "e▁or ▁revis", "urther mor", "▁until ▁subjects▁have▁access▁to▁commercially▁available▁product▁or▁for▁up▁to▁2▁year", "▁any ▁amendment", "IV ▁investigational▁product", "OX AL", "▁document ing", "▁Arm s▁A▁and▁D", "was▁ observed▁in", "was▁ chosen", "obtain ▁the▁consent", "▁AMG▁162 ▁in", "▁AMG▁162 ▁level", "▁17 5▁mg/m2", ",▁H ol", ",▁H ung", "▁then ▁treat▁based▁on", "OG -Ntx", "by▁ either", "▁chang e▁the▁", "-5 5", "stitution ,▁who▁will", "overall ▁progression▁of", "under ▁medical", "▁criteria :\n\n", "▁int ra-", "ship ment▁of", "must ▁also", ".▁For ▁this▁", "\n\nAn ▁observation▁made▁on▁a▁variable▁", "by ▁the▁treating▁physician", "▁OS ,▁the▁", "s▁of▁the▁ abdomen", "▁diseas e▁in", "▁diseas e;", "▁approv ed▁by▁", "▁approv ed▁in▁the▁", "known ▁to", "▁a▁c ardiologist", "▁K it", "efficacy▁ variabl", "▁Y ▁P▁O▁C", "(s) ▁must", "(s) ,▁and▁the▁", "assessment s▁", "s▁should▁be▁ representative▁of", "vention al▁CT", "vention s▁that▁result▁from▁this▁research.▁Neither▁Amgen", "represent ing", "▁new ▁cases▁of", ",▁G rade▁", "s▁on ▁Day▁1", "versus▁ placebo", ",▁et▁al .▁In", ",▁et▁al .▁M", ",▁et▁al .▁Irinotecan", "▁count ries", "ed▁c are", "▁chemotherapy ▁administration", "▁chemotherapy -na", "▁x▁x ▁x", "ing▁a ▁subject", "ing▁a ▁high", "ing▁a romatase▁inhibitor", "s▁and ▁are▁", "s▁and ▁those▁", "s▁and ▁amendments▁to", "research ▁using", "-m L", ",▁D ay▁", "▁part ially▁", "▁by \n\nthe▁investigator", "▁every▁ 2", "within ▁the▁past", "identifi able▁", "\n\n5 6", "\n\n5 7", "▁a▁m olecular", "▁compar ator", "▁14 ▁days", "▁mL ▁vial", "▁Appendix ▁C", "▁first ▁line▁", "-M elzack", "\n\nAppendix ▁J", "▁the▁first ▁documentation▁of▁", ",▁p aclitaxel", "IC F", "▁under ▁a", "indic ate▁", "indic ating", "21 ▁November▁2005", "▁+ ▁FOLFIRI", "PA RT", "ized▁ fil", "▁IV ▁bisphosphon", "olic it", "▁for▁the▁ final", "▁pos ition", ")▁( X", "▁Oncol ▁2", "normal ity", "ate /", "▁clinical▁ import", "\n\nO c", "▁between ▁the▁", "/m onth", "\n\n9 5%", "\n\n9 .3.1", "chemotherapy▁ in", "▁SAE s▁and▁those▁", "is▁not ▁positiv", "▁research ▁companies▁", "▁of▁a ▁treatment", "▁of▁a ▁21-day▁cycl", "▁confirm atory▁", "▁withdraw al▁of", "pecifi ed▁that", ",▁in fection", ",▁in formed▁consent▁form", "▁cl ot", "▁survival▁ rate▁", "new ▁version", "new ▁location", "person ▁who▁conducted", "ascular ▁endothelial▁growth▁factor", "rof ich", "▁hav e▁shown▁that", "▁hav e▁the▁sampl", "▁Treatment ▁of", "att ention", "▁the▁end▁of ▁study▁", "▁the▁end▁of ▁study▁treatment", "▁18 :", "▁and▁s kin", "▁and▁s unitinib", "▁and▁s upport", "pens ation▁for", "▁observ ed▁or▁volunteer", ",▁R e", ",▁R ob", "▁were▁ recorded,", "except ▁where▁", "due▁to ▁un", "▁overall ▁survival▁(", "▁significant ▁difference▁in", "▁is▁not ▁yet", "median ▁time▁to▁progression", "blood▁ pressure,▁", "y▁s hould▁", "analys es▁", "▁cor por", "\n\nProtocol ▁Synopsis▁", "Treatment ▁Arm▁A", "Treatment ▁Cycl", "ensitiv ity▁", "ECOG ▁45", "▁thes e▁drug", "........................................................................................................ .....▁", "▁advanced▁ esophag", "calcul ated▁to", "calcul ated▁based▁on", "Ex pression", "util izing", "es▁to ▁have▁access▁to", "▁serum ▁or▁urine▁pregnancy▁test", "▁medical▁ emergency▁", "▁EGF ▁receptor", "RECIST ▁Criteria▁for", "\n\nSection: ▁14", "26 0", "26 ]", "Pro tein", "▁PD ▁=▁progressive▁diseas", "▁an▁ enrollment", "▁an▁ electronic", ".▁L esion", "▁prior ▁chemotherapy▁regimen", "▁condition s▁", "▁consent ▁to▁the▁", "▁patients▁who ▁received▁", "post erior", ",▁T ulsky▁", "use▁of ▁radioisotopes),▁surgery▁to", "▁the▁date▁of ▁withdrawal", "2- 9", "urger y", "▁acid s▁and▁", "echn etium", ",▁K aplan-Meier", "▁either ▁occur", "▁either ▁“", "▁record s▁will▁be▁", "hav e▁shown", ".\n\nE THICS", "▁those▁ with", "▁those▁ patients▁", "\n\nin creas", "ensor y", "cycl e\n\n", "cycl e)", "weight ▁and▁", "\n\nm etastas", "cover ing", ".\n\n5 .7", "Amgen ▁Center", "Assessment s\n\n", "LY231514 \n\nH3E-US-S130(d)▁Clinical▁Protocol\n\nPage▁", "▁procedure s▁will▁be▁", "▁toxicity ▁that", "wer e▁treat", "hemat ological", "ett ▁CL", ".\n\nD enosumab", "possibl e,▁", "representativ es▁to▁have▁access▁to", "product s▁develop", "▁last ing", "\n\na \n\nb", "▁would▁ otherwise▁", ".\n\nIn ▁some▁circumstanc", ".\n\nIn ▁signing▁this▁document", "ey es,▁", "ation,▁ etc.", "▁denosumab ▁concentration", "adverse▁event ▁case▁report▁form", "▁evaluation ▁by▁", "▁(C ycle▁", "▁(C 225", "▁(C EA", ".▁In▁addition ▁to", "plann ed▁to", "Endpoint s:", "▁are :\n\n", ".4.1 .2", "▁is▁a ▁requirement", ".\n\n3 2", "▁the▁sponsor ’s▁", "▁CTCAE ▁version▁3.0", "▁CTCAE ▁v3.0", "itis▁ (", "app end", "▁studies▁ with", "3- week", "▁All ▁other▁lesion", "condition ▁of▁the▁drug", ".\n\n7 .3", "▁50 ▁ml/min", "Ph osph", "▁schedul e▁(", "▁consider ed", "▁En roll", "/d epression", "▁tumour ▁sampl", "▁tumour ▁siz", "ed, ▁then", "▁colon ▁carcinoma", ",▁m ulticenter", "inf used▁", ",▁N ak", "▁accordance▁with ▁ICH▁GCP", "non measurable▁lesion", "non linear", "other▁than ▁SAEs▁and▁those▁", "e▁sampl es", "▁the▁data ▁cutoff", "▁appropri ately", "leucovorin ,▁", "experienc ed▁an", "rang e▁from", "controll ed▁by▁", "▁Safety▁ Analysis", "▁vitamin▁D ▁and▁", ").▁The▁ original▁sign", ".\n\nB oth", "combin ed", ",▁but ▁must", "AR D", "Appendix ▁B", "radiation ▁treatment", "high er▁than", "▁detail s▁of", "treat ed▁as▁", "Ther apies", "▁local ised▁", ",▁all ▁subsequent", "▁a▁l og", "▁a▁l ist▁of", ",▁E inh", "skin ▁reaction", "maintain ▁a▁list▁of", "increas ed", "▁PSA ▁valu", "ethyl en", "▁objective▁ disease▁progression", "▁objective▁ response▁rate▁", "Follow ▁Up", ".\n\n2 .4", "▁more▁than ▁on", "▁Dose▁ reduction", "▁one▁ year", "adjust ed▁for", "▁local▁ lab", ",▁c ardiac", ",▁c olorless", "Evalu ation▁of", "Evalu ations▁", "Med ic", "Med ian", "▁function al", "90 5", "▁physician ,▁or▁other", "▁take▁ plac", "▁take▁ appropriate▁", "sol vent", "▁grade▁ 2▁or", "▁et▁al.▁200 4", "▁et▁al.▁200 2)", "primary ▁tumor", "primary ▁analysis▁of", "rain ing", "\n\nNo ▁change\n\n", "\n\nAmgen ▁Protocol▁Number", "▁en d▁", "▁en able▁", "read y", "read ily", "reduc ed▁", "▁my▁ illness", "▁my▁ records▁", "reported▁ SAE", "reported▁ immediately", "evaluated▁ using", "▁(P IN", ".▁At ▁each", "ate,▁ 5%", ".▁5 7", "s▁should▁ be▁taken", "▁DNA ▁extraction", "period ic", "▁FOLFIRI ▁plus▁placebo", "metastatic ▁breast▁cancer", "activ ity▁in", "▁standard▁ chemotherapy", "▁60 ▁mg", "▁studies ,▁the▁", "▁current ▁practic", ",000 ▁women", "\n\nb efore▁", "\n\nb aselin", "▁possibl e,", ",▁O z", ".\n\nR andomization", "▁expos ure▁of", "urine▁ protein", "ECG s▁may▁be▁performed▁as▁clinically▁indicated", "best ▁possible▁", "▁a▁subject ▁has▁", ".▁Con comitant▁medication", ".▁Con firmation", "▁Study▁D ocumentation▁and▁", "▁the▁discretion ▁of▁the\n\n", ",▁w ould▁", "▁the▁primary ▁and▁secondary▁", "s,▁or ▁research▁companies▁", "outlin ed▁below", "outlin ed▁in▁Appendix", "ase▁( AST", "ology,▁ blood▁", "tic ▁syndrom", "▁the▁sampl e▁to▁be▁", "submitt ed▁for", "4▁week s▁on", "ane ous▁", "e▁blood▁ sampl", "▁normal ization", "us▁( ECOG", "IVRS ▁vendor", "▁(cid: 14", "sp ection▁of", "▁the▁sit uation", "▁plann ing", "▁pre- medication", "judg ment▁of", "▁necess ary▁for", "results▁of ▁a", "modification s▁for", "IS S", "term ▁“", "\n\nCONFIDENTIAL \n\nA▁®\n\nd▁e▁v▁o▁r▁p▁p▁A\n\nProduct:▁PANITUMUMAB▁(AMG▁954)▁Protocol▁Number:▁20040249▁Date:▁07▁August▁2007\n\nPage▁", ".▁Ex ploratory▁", "\n\nEx ploratory", ",▁then ▁the▁", "ert iary", "los s▁to▁follow-up", "eng ineer", "▁the▁patient’s▁ underlying", "\n\nto ▁the▁", "▁and▁other ▁researcher", "▁ext end", "sid ed▁", "▁surger y▁(", "confidential▁ information▁of", "▁written ▁approval", "▁question ▁is▁", "s▁may▁ us", "s▁may▁ prescribe▁", "s)\n\n \n\n", "s.▁S ever", "▁systemic ▁therapy▁", "▁estim ate▁th", ".\n\n4 .2", "\n\nCon comitant▁medication", "▁lin ear", "▁this▁research ▁will▁compensate▁you▁if▁this▁happens", "es▁of▁the▁ medical", "▁................................................................................ .....▁", "before▁ any▁", "e.▁A mgen", "▁defin ed▁", "▁Tumor ▁Lesion", "▁With :", ")▁is▁ defined▁as▁", "FOLFIRI ▁arm", "final ▁analysis▁for", "stable▁ for", "▁AD MINISTRATIVE", "▁active▁ agent", "▁active▁ infection", "▁blood ▁test", "▁blood ▁and/or", "improv ed▁", "unblind ing▁in", "▁EGFR ▁inhibitor", "cr is", "poss ib", "Not ▁Done▁(ND", "Sign ificant", "▁outcom es▁", "▁outcom es▁of", "▁........................................................................ .....▁", "s▁must ▁be\n\n", "▁appl ies", "permitt ed", ".▁The▁patient ▁has▁a", ".▁Treatment s▁Administer", "▁dose▁reduction s▁and▁", "▁assess▁the▁ effect▁of▁ZD4054▁in▁combination▁with▁docetaxel▁on", "az ep", "\n\nTreatment ▁compli", ".\n\nTo ▁investigate▁the▁", "remov ed▁for", "▁prevent ing", "▁imaging ▁test", "completion ▁or▁early▁termination▁and▁send", "▁or▁s ell", "▁or▁s uspect", "\n\nc opy▁of", "▁achiev e▁the▁", "▁cyt ologic", ".▁There▁ is▁", "ret riev", "▁nam es▁for", "▁de cline▁", ".▁This \n\n", "kaline▁ Phosph", "wher e▁the▁in", "▁mCRC ▁among▁subjects▁with", "▁the▁investigator’s▁ report", "▁et▁al,▁200 4)", "cod e▁break", "otherwis e▁specifi", "▁siz e;", "▁4.6 .1.1", "▁sites▁of ▁disease", "MUNEX \n\nConfidential\n\nAMGEN", "co protein", "rig ger", "▁Require d", "▁participating ▁countries▁", "estimated▁ using▁the▁", "system ▁organ▁clas", "ectom y,▁", "ectom y/", "▁will▁be▁used▁to ▁identify", "local▁ laboratory▁", "local▁ lab", "EL IS", "Qual ity", "RR =", "▁of▁s ingle-agent", "▁enter ▁the▁", "▁co /", "▁co efficient", "(106 )\n\nGEL▁Version▁ID:▁ONC.000−", "ically▁significant ▁adverse▁events▁", "▁Coll ege▁of", "quant ities▁of", "▁shown ▁to▁be▁", "▁thromb otic", "jur y▁", ".\n\nH owever", "concomitant▁medication s▁will▁be▁", "ous▁in jection", "▁2▁week s▁prior▁to", "administered▁ over", "\n\nPrimary▁ variabl", "(m L/min", "investig ated▁in", "▁and▁p ackag", "pleas e▁see▁Section", "▁(B UN", "included▁in ▁the▁shipment", "begin ning▁of▁the▁", "▁grade▁3 /4", "▁respon d▁to", "▁respon dent", "▁analysis▁will ▁not", "▁describ ed▁abov", "representative▁ and▁", "▁(if ▁applicable)", "▁undergo ▁an▁", ".▁Study▁ Population", "CEDURES ▁IN▁CASE▁OF▁EMERGENCY,▁OVERDOSE▁OR▁PREGNANCY", "▁resolution ▁to", "3,▁ 6", "had ▁the▁opportunity▁to", "▁copy▁of ▁the▁", "▁stopp ing▁the▁", "Follow-up ▁Visit", "effective▁ contraception", "Analysis▁ Data", ".▁19 82", "▁of▁panitumumab ▁plus▁FOLFIRI", "icalutam id", "▁interest ▁in▁the▁", "e▁an ▁objective▁", "involv ement", "▁as▁describ ed▁in▁Appendix", "▁standard ized▁", "acceptable▁to xicities", "FDA ▁form", "antic oagulant", "▁experience▁ a", "▁the▁two ▁treatment▁group", "▁know ▁which", "▁and▁all ▁amendment", "▁while▁ you▁are▁", "scor ed▁as▁", "▁bo ard", "▁dep artment", "every ▁three▁week", "▁(Arm ▁1", "▁patients▁treated▁with ▁bevacizumab", "▁prolong ation▁of", "\n\nLY231514 \n\nH3E-US-S130(d)▁Clinical▁Protocol\n\nPage▁", "▁comparison ▁of", "PSA ▁values", "s▁to▁the▁ appropriate▁", "from▁the▁ IEC/IRB", "related ness▁of", "▁a▁maximum ▁of▁", "▁progress ed▁after", "ology▁and▁ Pharmacokinetic", "ed; ▁however", "▁any▁reason ,▁", "aminotransfer ase\n\n", "▁related▁to ▁that", "cop e▁of", "meet ing", "▁thos e▁subject", "ody▁ S", "ili ary▁", "▁(d arbepoetin▁alfa", ".▁Sampl es▁will▁be▁", "puter ized▁", ",▁19 82)", "▁procedure▁ (", "▁unblind ing▁information", "s.\n\nP artial▁", "▁original ▁dose\n\n", "diagnos ed▁with", "shipp ed▁to", "withhel d", "▁compens ated▁for", "▁result▁in ▁hospitalization", "▁particular ▁clinical▁import", "escription ▁of", "▁delay s▁in", "▁CO MP", "perman ently", "▁aspect s▁of▁the▁", "shown ▁in▁Table▁", "▁there▁is▁a ▁reasonable▁", ".▁Al tern", "reath ing", "▁altern ative▁to", "▁altern ative▁treatment", "radiograph ically▁", "roughout ▁the▁study", "e▁J A", "accur ate▁", "▁5% ▁Dextros", "▁telephone▁contact ▁with", "▁µ mol/L", "▁measur ing", "notification ▁to▁Pfizer", "▁subjects▁will▁be▁ followed▁for▁survival▁for", "\n\n14 .▁REFERENCES", "hould ▁a▁subject▁(or", "s▁thereafter ▁until", "▁urine▁ protein", "▁(L awless", ".\n\nThe▁investigator ▁will▁be▁responsible▁for▁obtaining▁an", "rupt ▁until", "▁cardiac ▁failure▁", "anti- tumor", "▁Chemotherapy▁ Al", "▁Dose▁Modification ▁Algorithm", "decision ▁by▁the▁investigator▁or", "▁of▁69▁Addendum▁13 \n\n", ".▁Onc ogen", "▁ren al", ".▁Am▁J ▁Clin▁Oncol", "\n\nX▁X \n\nX▁X", "\n\nAny \n\nYes", "▁confirmed▁ CR▁or▁PR", "▁immediately▁ if", "e▁B lood▁", "line▁ strok", "\n\nI▁am ▁satisfied▁with", "▁at▁any▁tim e▁by▁", "▁protocol▁amendment s▁and▁", "▁is▁in ▁effect", "▁Hy per", "▁Hy po", "\n\n100 %▁of▁previous▁dose\n\n", "▁oral ▁bisphosphon", "▁will▁be▁censored▁at ▁the▁last", "▁their▁last ▁observation", "oz n", "▁will▁be▁record ed", "intraven ous", "\n\nGen eral", "\n\nAdd▁3 ,5,6", "standard▁of ▁care▁", "ped it", "\n\nFollow ing▁the▁", "acceptable▁ adverse▁event", "▁alloc ation▁of", "▁alloc ated▁to", "▁at▁each ▁centr", "▁90 ▁", "SU E", "▁the▁use▁of ▁your", "▁soft ▁tissu", "▁2.5 ▁x▁ULN", "▁the▁second▁ interim▁analysis", "may▁occur ▁in▁10", ").\n\nP age:", "▁Analysis▁ Population", ";▁( 4)", "local ▁practic", "well▁toler ated▁in", "▁ep idemi", "\n\nGEL▁Version▁ID:▁ONC.000− 272−636.4.0", ".▁Your ▁doctor", "▁will▁provid e▁the▁", "s▁(or ▁equivalent", "▁any▁un expected▁s", ".▁Rec ent", "▁mmol/L ▁mmol/L", "Related▁ Event", "bal ance▁", "hold ▁and▁check", "▁facil it", "data▁from ▁a", "metab olic", "recruit ed▁into", "recruit ment▁of", "▁(I FL", "s.▁C lin", "▁death▁or ▁hospitalization", "▁Pharmac y▁Guid", "target \n\nlesion", "physical ▁well▁being", "▁the▁development▁of ▁commercial▁pharmaceutical▁product", "▁trial▁of ▁pemetrexed▁", "Cont act", "investigational \n\nproduct", "▁inclusion ▁cutoff▁date▁", "content s▁of", "▁vis ceral", "storage▁ period", "▁will▁be▁the▁ primary", "correction ▁fluid,▁or", "▁the▁definition ▁of▁a", "ranslational▁ research", "s▁by ▁the▁", "phosphor yl", "ART ▁B", "▁body ▁authorized▁under▁applicable▁law▁to▁consent", "▁twic e▁daily;", "2▁or ▁has▁returned▁to▁baseline,▁then", "incid ence,▁", "▁and▁pro pri", "▁and▁pro mptly▁", "partial▁ response▁", "re▁ T", ",▁U SA", "ed,▁and ▁accurately▁", "▁bound aries", "▁Sodium ▁Acet", "▁will▁be▁compared▁ between", "▁80 5", "▁understand ing▁of▁the▁", "clearly▁ defined▁and▁surrounded▁by▁aerated▁lung", "elf-care .▁Totally▁confined▁to▁bed▁or▁chair", "/FA CT", "▁ill ness▁or", "revis ed▁to", "▁molecular ▁weight", "\n\nScreening ▁and▁demographic", "cyt otoxic", "mic id", "▁urin ary▁", "orb itol", "▁the▁point ▁at▁which", "▁your▁cancer ▁has▁", "documentation ▁related▁to▁that", "▁non-small▁cell▁lung▁cancer ▁(NSCLC)", "▁Exploratory▁ ................................................................................................", "\n\nS▁T▁I\n\nK▁C▁E▁H▁C\n\nE▁S▁A▁E▁L▁P\n\n.▁T▁N▁E▁M▁U▁C▁O▁D \n\nC▁I▁N▁O▁R▁T▁C▁E▁L▁E", "’s▁in stitution,▁who▁will", "ance,▁ other▁than▁SAEs▁and▁those▁", "NS )", "s▁m ight", "▁second▁ line▁", "recorded▁on ▁a▁Serious▁Adverse▁Event", "▁No▁No ▁No▁No", ",▁they▁ must", "negative▁ or", "▁I.V .▁", "▁will▁be▁analyz ed▁using", "▁Mod el", "▁Good▁Clinical▁Practic e▁and", "s.▁In▁addition ,▁the▁", "pedited▁ report", "instructed▁to ▁contact", "▁wish▁to ▁assign▁the▁study▁records▁to", "▁tyrosine▁kin as", "▁will▁be▁consider ed▁a", "s▁for▁each ▁endpoint", "▁-▁- ▁-▁-", "▁the\n\nsubject ▁or", "▁OS▁event s▁are▁", ",▁creatinin e,▁", "▁summar iz", ".2\n\nR andomization", "prolong ed▁(", "▁SU PP", "▁heart beat", ".▁During▁the▁ extension▁period", "othelin -1", "▁activities▁ of", "summarized▁ descript", "▁em ail", "▁every ▁two▁week", "▁Hematologic ▁Toxicity▁", "\n\nDescription ▁of▁outcome▁variables▁in▁relation▁to▁objectives▁and▁", "▁antif ol", "\n\n4\n\n4\n\n4\n\n4 \n\n4\n\n4", "unctional▁Assessment▁of▁Cancer▁Therapy▁ –", "▁of▁63▁Finalization▁date:▁June▁19▁2001,▁Incorporating▁Amendment▁3▁–▁dated▁23▁May▁200 3", "famil iar", "ysesthes ias▁", "▁nor ▁the▁principal▁investigator", "▁Histor y", "▁Histor y▁of", "▁weekly ▁then▁treat▁based▁on", "\n\nDisease▁ progression", ".▁During ▁this▁", "▁superior ity", ".\n\nAdd▁ 6", "protect ive▁", "cagliotti ▁et▁al.▁200", "creatinine▁clearance▁ (CrCl", "▁evidenc e▁that", "▁and▁placebo ▁group", "▁Compar ison", "▁third -", "▁ECOG▁performance▁stat us▁", "▁stopping ▁boundary▁", "aries▁ for", "▁squamous▁cell ▁carcinoma▁of▁the▁head▁and▁neck", "▁of▁at▁least ▁2", "▁the▁event▁that ▁bone▁scan", "▁nonhematologic ▁toxicities", "regulatory▁ag encies", "(106)\n\nGEL▁Version▁ID:▁ONC.000−272−636.4.0\n\nApproved\n\nDate▁Printed:▁13−Aug−2013\n\nApproved▁by\n\n13▁Sep▁2007▁17:17:03\n\nAmended▁Clinical▁Study▁Protocol▁Drug▁Substance▁Cediranib▁(RECENTIN,▁AZD2171)▁Study▁Code▁D8480C00013▁Edition▁Number▁3▁Date\n\n .▁E▁S▁U", "▁the▁time▁point s▁", "▁efficacy▁and▁ safety", "enn ett▁CL", ",▁other ▁researcher", "▁cess ation▁of▁", "▁rect al▁cancer", "▁hemat ological", "\n\nStudy ▁timetable▁and▁end▁of▁study", "ured ▁and▁packag", "▁stage▁III ▁colon▁cancer", "▁data▁collection ▁for", "▁Stor age▁", "resolved▁or ▁stabiliz", ".▁Therefor e,▁the▁", "▁ruler ▁or▁c", "▁withdrawal▁from ▁study▁treatment", "▁metab olism", "whichever▁is▁ later", "Number :", "doubl e▁barrier", "s▁used▁in ▁this▁protocol,▁the▁", "▁paper ▁forms▁will▁be▁", "▁the▁design ated▁", "over▁30 ▁minutes▁", ".▁Concomitant ▁Therapy▁", "PTV ▁receives▁", "▁archiv ed▁tumor▁tissu", "(7 ):▁p.▁", "anin e-", "▁bal anc", "▁bal ance▁", "randomized▁to▁receive▁ panitumumab", ".\n\nHow ▁will▁the▁confidentiality▁of", "▁Organization ▁for▁Research▁and▁Treatment▁of▁Cancer", "▁reasonable▁possibility▁that▁the▁event▁may▁have▁been▁caus ed▁by▁", "(10 ):", "poly glutam", "proper ly", "amide▁ ribonucle", "▁RS ,▁Rubin", "▁dose▁escal ate▁to", "\n\nx▁x▁x▁x \n\nx▁x▁x▁x", "wild-typ e)▁KRAS", ",▁on ▁behalf▁of▁a", "▁PT V", "▁Dr ive▁", "per▁local ▁practic", ".▁Re gression▁models▁and▁", "▁behalf ▁of", "▁pattern s▁of", "andler ▁A", "▁after▁failure▁of ▁a▁docetaxel-based▁chemotherapy▁regimen", "▁physical ▁activity", "pontane ously▁", "▁reli ef", "▁count,▁ RBC▁count,▁hemoglobin", "▁these▁data ▁into▁the▁", "\n\nSection:▁Appendix ▁K:▁Informed▁Consent", "FACT-L/N tx", "DI TIONS", "TRIO ▁Safety▁Officer", "born ▁bab", "▁famil y,▁", "▁are▁being ▁asked▁to", "▁may▁experienc e▁include▁", "▁CT▁or▁MRI▁scan ▁of▁your", "▁correl ate▁with", "▁Plus▁ D", "Fract ure", "First -line▁", "ei ra", "uperior ity▁of", "▁ir rit", "inspect ed▁visually▁for", "s▁................................................................................ .....▁", "▁sus pension", "▁singl e▁dose▁", "charg e▁s", "integr ity▁of", "\n\nRationale▁for ▁Chang", "▁Panitumumab▁Clinical▁ Efficacy▁", ".▁Mor eover", "hazard▁ratio▁for ▁placebo▁relative▁to", "Hypothes is", "field▁ MR", "account ability▁of▁all", "▁Platelet ▁count", "study\n\n drug", "▁will▁sign ▁the▁final", "consecutive▁ 12-lead▁ECG", "▁overdose▁ with", "▁SD▁PD ▁Any▁", "▁legally▁acceptable▁representativ e)", "unequivoc ally▁", "ies▁must▁be▁ made▁available▁for", "▁G4PFS ▁and▁PFS", "▁discontinues▁ dos", "risk▁factor s▁for", "systemic ▁steroid", "▁Schedule▁4/ 2▁(", "/G OG-Ntx", "hom e▁and▁", "▁and▁document s▁to▁determine▁whether", "acet amol", "convention al", "\n\nRefer ▁to▁the▁", "every▁3▁months▁ ±", "▁accurac y", "▁the▁day▁after ▁the▁patient▁and▁the▁investigator▁agree▁to", "▁a▁drug ▁or▁drug▁delivery▁system", ",▁201 7", "▁single- use▁vial", "▁AL L", "osc opy", "\n\nSerious▁Adverse▁Event ▁Reporting", "white▁blood▁cell ▁count", "▁respir atory▁tract▁infection", "dermat itis", "s\n\n9 .1.1", "\n\nAdminister ▁panitumumab▁@", "▁administered▁to ▁the▁subject", "____________ _", "awa ▁Y", "made▁available▁to ▁member", "colony-stimulating▁factor ▁(G", "ranc h", "uniqu e▁to▁the▁individual", "▁ful fill", "ovarian ▁cancer", "▁cycle,▁ hold▁and▁check", "▁change▁from▁baseline▁in ▁lumbar▁spine▁BMD", "▁disease, ▁ascites,▁pleur", "quality▁ control", "closely▁ monitor", "ed▁to▁the▁extent ▁of▁the▁", "▁persons ▁authorized▁to", "ayo▁Clinic ▁Rochester", "is▁an▁open-label ,▁randomized,▁multicenter", "Month ▁24", "pet itive▁", "▁CH F", "▁Pregnancy▁ Test", "▁PET▁scan s▁or▁s", "investigator▁should▁ maintain▁a▁list▁of", "ERC OR", "▁active▁treatment ▁than▁on▁placebo", "jeopardiz e▁the▁subject", "LA SA", "▁(not ▁necessarily", "\n\nAST ▁(SGOT", "JMHO .1", "▁Page▁1 ▁of▁1", "\n\nInternational▁ Conference▁on▁Harmon", "▁its▁representativ es", "refractor y", "refractor y▁to", "reliable▁ data", "▁Kaplan-Meier▁method s▁and▁", "▁<> ▁Version▁Date:▁<>", "http:// www.", "surg ically▁steril", "entan yl", "anders▁ J,▁Kaplan", "ips ilateral▁", "curric ulum▁vita", "e▁dail y▁(", "iomet rik", ",▁Mur ray▁", ".▁Journal ▁of▁the▁National▁Cancer▁Institut", "▁and▁scientific ▁judgment", "comparative▁ analysis▁of", "rochure▁ for", "▁rate▁( GFR", "paid▁ for", "▁controlled▁ room▁temperature▁", "Wild-type▁and▁ Mutant▁KRAS", "▁assess▁the▁effects▁of▁ZD4054 ▁in▁combination▁with▁docetaxel▁on", "icens ee", ".▁or ▁sponsor-nominated▁CRO", "ed▁and/or ▁compensated▁for", "▁top ical", "▁(WBC ▁count,▁RBC▁count,▁hemoglobin", "antitumor ▁activity▁of", "▁alkaline▁phosphat ase▁", "ALITY ▁ASSURA", "▁(AMG▁162 ▁or▁placebo", "▁he/sh e▁", "bronch ospasm", ",▁standard▁ deviation,▁", "esid e▁the▁error", "▁to▁another ▁location,▁", "▁offic er", "ouill ard▁", "agic ▁event", "▁lot ▁number", "ecret ed▁", "▁on▁Days▁ 1▁and▁8", "▁Lead▁ Period", ")\n\n2 1-Jul-2008▁Version▁number:▁1▁(electronic▁2.0", "▁the▁det erior", "▁may▁requir e▁intervention", "sertion ▁of▁the▁correction", ",▁Safety▁ Evaluation", ",▁Pat el", "▁minutes▁on▁Day▁1 ▁of▁each▁cycl", "General▁ (FACT-G", "contraceptive▁ precaution", "▁the▁baseline▁sum ▁longest▁diameter", "85% ▁power", "Epidermal▁ Growth▁Factor▁Receptor", "vinc rist", "ed▁appropriate▁ by▁the▁investigator", "▁Steering ▁Committee", "whos e▁tumor", "▁from▁the▁treatment ▁portion▁of▁the▁trial", "OLFOX- 4", "EGFR- pathway", ",▁all▁subjects▁ currently▁undergoing", "▁a▁legally▁acceptable▁ representative)", "Safety▁Follow-Up ▁visit", "▁minutes▁prior▁to ▁paclitaxel", "▁Non-metastatic ▁Prostate▁Cancer", "30-day▁postdiscontinuation▁follow-up▁visit ▁occurs▁at▁or▁near▁the▁end▁of▁the▁", "differenc es▁in", "cagliotti▁G V", ",▁Bonom i▁P", "▁Supportive▁C are▁", "willing▁or▁unable▁to ▁comply▁with", "Kaplan ▁and▁Meier", "Toxic ology▁and▁Pharmacokinetic", "Women ’s▁", "▁particulate▁matter ▁and▁dis", "resist ance▁to", "verifying ,▁and▁reproducing▁any▁records▁and▁report", "end-of- study", "s\n\n3 \n\nCapable▁of▁only▁limited▁s", ".▁Initial ▁serious▁adverse▁event▁information", "aresthes ias/d", "results▁will▁not▁be▁ plac", "▁response▁or ▁stable▁disease▁", "modality▁ should▁be▁", "▁dispos al", "▁administered▁a ▁pharmaceutical▁product", "▁a▁member ▁of▁the▁study▁staff", "▁ABI-007▁and▁ TAXOL", "g/m2) ▁100", "\n\nPharmac ogenetic", "▁chemistry▁and▁ hematology▁", "▁2▁years▁after▁the▁last▁dose▁of ▁blinded▁IP", "begins▁on ▁the▁day▁after▁the▁patient▁and▁the▁investigator▁agree▁to", "statistical▁analysis▁of ▁the▁study▁is▁to", "-related▁activities ▁and▁documents▁to▁determine▁whether", "disclosed▁to ▁anyone▁", "organ▁function ▁as▁defin", "AEs▁leading▁to ▁discontinuation▁of▁the▁", "able▁to▁Evaluate▁(UE ):", "-associ ated", "▁room ▁temperature", "on▁first ▁demonstrating▁a▁significant", "▁(week ▁5", "ency▁or ▁drug▁abus", "ritish ▁Journal▁of▁Cancer", "may▁patent ▁or▁sell", "▁days.▁The▁ 30-day▁postdiscontinuation▁follow-up▁visit▁occurs▁at▁or▁near▁the▁end▁of▁the▁", ",▁magnesium,▁creatinine,▁albumin,▁total▁protein,▁total▁bilirubin ,▁alkaline▁phosphatas", "▁participants▁in ▁this▁research▁will▁compensate▁you▁if▁this▁happens", "▁identified▁and▁reported▁lesion ▁at▁baseline▁and▁", "▁Oxaliplatin/ ▁5-fluorouracil/▁leucovorin", "one▁scintigraphy▁ is▁not", "▁taking▁as▁reference▁the▁nadir ▁SLD", "▁demonstrate▁a▁statistically▁significant ▁effect▁in", "\n\n(continued)\n\nH3E-MC-JM IG(f)▁Clinical▁Protocol", "ERIOUS ▁ADVERSE▁EVENT", "▁and▁lasts▁approximately▁30 ▁days.▁The▁30-day▁postdiscontinuation▁follow-up▁visit▁occurs▁at▁or▁near▁the▁end▁of▁the▁", "▁survival▁prob ability▁", "IGNAT URES", "at▁weeks▁ 8,▁12", "▁and▁enter ▁these▁data▁into▁the▁", "chi ectom", "▁promis ing", "s▁(t emperature,▁blood▁pressure,▁", "▁Intern ▁Med▁", "▁your▁treatment ▁course", "care▁but ▁unable▁to▁carry▁out▁any▁work▁activities.▁Up▁and▁about▁more▁than▁50%▁of▁waking▁hour", "mainten anc", "document▁contains▁ confidential▁information▁of", "▁Cancer▁J ▁Clin", "▁IV▁antibiotic ▁or▁IV▁antifungal", "ephro tic▁syndrom", ".▁You▁will▁also▁be▁ ask", "lymphangitis▁ cutis/pulmonis", ")▁and▁their ▁suitability▁for▁accurate▁", "s▁during▁the▁study▁treatment▁period▁or ▁during▁the▁", "▁prostate-specific▁antigen ▁(PSA)", "▁will▁be▁the▁primary▁ population", "-Reported▁Outcomes▁(PRO s)", ".▁Eligibl e▁subject", "identified▁as▁non-target▁lesion s▁and▁", "▁measurable▁lesions▁up▁to▁a▁maximum▁of▁5▁lesions▁per▁organ▁and▁10 ▁lesions▁in", "EDTA▁blood▁[plasma▁and▁cell▁pellet],▁PAXgen e▁blood▁[RNA", "eropol ▁N", "UBL IC", "x2 ▁factorial", "ineph rin", "ing▁it ▁crit", "▁business▁ day", "▁reject ing▁the▁", "▁li eu", "▁the▁sum ▁of▁", "s,▁ECG ▁and▁physical▁examination", "▁acet aminophen", ".\n\nPh armacokinetic", "▁must▁be▁report ed▁in▁accordance▁with▁the▁", "▁years▁after▁the▁ main▁study▁is▁", "mitted▁to ▁Biomedical▁Journal", "normalized▁ ratio", "andomised,▁ Double-blind", "rofolate▁ reduct", "vestigational▁New ▁Drug", "implication s▁for", "▁requiring▁s ystemic", "Investigational▁Product▁Accountability▁ Record", "30-day▁postdiscontinuation▁follow-up▁period▁ begins▁on▁the▁day▁after▁the▁patient▁and▁the▁investigator▁agree▁to", "▁all▁randomized▁subjects▁have▁ completed▁their", "▁expected▁to▁benefit ▁you▁directly▁or▁to▁alter", "▁Study▁to▁Compare▁the▁Efficacy▁of ▁Panitumumab▁in▁Combination▁with", "Sublingual▁Intramuscular▁Intravenous▁ Oral▁Rectal▁Subcutaneous▁", "▁was▁unable▁to▁be▁evaluated▁leading▁to ▁an▁inability▁to▁determine▁the▁status▁of▁that▁particular▁tumor▁for", "▁Electronic▁Data ▁Record", "cGill -Melzack", "kal emia", "▁of▁Health ▁and▁Human▁Servic", "e▁see▁the▁ current▁version▁of▁the▁", ".▁STA TISTICAL▁CONSIDERATIONS", "▁death,▁whichever ▁occurs▁first", "e.▁When ▁the▁evaluation▁of", "▁my▁medical▁information ▁if▁I", "re-start ed▁at▁the▁", "CHED ULE", ",▁Ver we", "DNA▁methyl transfer", "▁modified▁version▁of▁the▁ RECIST▁criteria", "irradiated ▁area", "▁(KM) ▁time▁to▁event", "Return▁of▁Investigational▁Product▁for▁Destruction ▁Form", "aborative▁ Group", "▁the▁duration▁of▁the▁study.▁Copies▁of ▁the▁investigator’s▁report", "mg/m2▁IV▁over▁2 ▁hr", "▁3▁x▁ULN▁(if▁liver▁metastases▁ ≤▁5▁x▁ULN", "Comprehensive▁Cancer ▁Network", "preservative▁free▁liqu id▁in", "discoveries,▁or ▁derivative▁material", "▁Staging▁Manual,▁S eventh▁Edition", "Handbook▁for ▁Investigator", "abbinavar ▁F", "neo-)adjuvant ▁(radi", "have▁been▁answered▁to▁your▁satisfaction .\n\nIn▁signing▁this▁document", "▁“on-study” ▁death", "cen ario", "iPLEX ▁G", "icos apent", "allpoint ▁pen", "Inflammatory▁ Drug", "▁will▁be▁manufact ured▁and▁packag", "▁x▁ic ▁", ",▁Somer field▁MR", ",▁Grif fin", "labeled▁per ▁site▁", "▁AND▁QU ALITY▁ASSURA", "s.▁Amgen ▁and▁other▁researcher", "▁of▁10▁mM ▁Sodium▁Acet", "made▁only▁with ▁the▁prior", "▁named▁ representatives▁to▁have▁access▁to", "consent▁form▁should▁be▁provided▁to ▁the▁subject▁or", "perty▁of▁the▁sanofi-aventis▁group▁-▁strictly▁confidential▁WW-CLIN-PR007-SD-03▁VERSION▁n°02▁(19-DEC-2005 )\n\n21-Jul-2008▁Version▁number:▁1▁(electronic▁2.0", "▁Manuscript s▁Sub", "▁is▁inadvert ently▁", "refer▁to▁the▁current ▁Panitumumab▁Investigator’s▁Brochure▁for▁further▁detail", "▁will▁have▁access▁to ▁my▁medical▁information▁if▁I", "▁study-related▁record s▁without", "▁interval▁is▁ prolonged▁(", "regulatory▁agency▁ inspector", "regulatory▁agency (s),▁and▁the▁", "▁the▁benefit:risk▁profile▁ is▁not▁positiv", "▁First▁Street ▁SW", "epatitis▁C ▁virus", "ance▁in▁Investigational▁Product ▁Administration", "ed▁while▁on▁or▁after ▁prior", "▁make▁entries▁and/or ▁correction", "he/she▁must ▁notify▁", "unn▁PA ▁Jr", "▁intellectual ▁content", "▁must▁submit▁and ,▁where▁", "residual▁lesion ▁be▁investig", ".▁These▁signatures▁will ▁indicate▁that", "▁ever▁comes▁first.▁If ▁the▁benefit:risk▁profile▁is▁not▁positiv", "ensive▁treatment▁in▁an▁emergency▁room▁or▁at▁hom e▁for", "▁party▁or▁move▁them ▁to▁another▁location,▁", "read▁the▁attached▁protocol ▁entitl", "6▁plann ed▁cycl", "Hu EPO", "kilogram s)", "al▁Anti- Inflammatory▁Drug", "uration▁for ▁Participant", "▁COLL ECTION", "acquisition▁of ▁informed▁consent", "▁or▁EC HO", "uties.▁All ▁persons▁authorized▁to", "ize▁discover ies▁or▁in", "▁nor▁other ▁participants▁in▁this▁research▁will▁compensate▁you▁if▁this▁happens", "▁and▁as▁needed ▁thereafter", "▁TIS SUE", "▁RIS KS▁AND▁DISCOMFOR", "event-free▁rates▁ at", "clude▁the▁s election▁of", "ing▁the▁articl e▁or▁revis", "▁at▁start▁of ▁cycle,▁hold▁and▁check", "▁study▁initiation ▁and▁as▁needed▁thereafter", "s▁and▁p-valu es", "s▁and▁investigative▁ staff", "ly▁as▁possible▁ up▁to", "reported▁according▁to▁the▁ protocol", "stront ium", "▁913 20", "ightCycl er", "▁Study▁Code:▁D8480C00013 ▁Version▁No:", "▁im▁= ▁intramuscular", ",▁a▁commercial▁pharmaceutical▁product ▁may▁be▁develop", "es▁will▁be▁assign ed▁for▁each", "ebrid ement", "▁drug▁depend ency▁or▁drug▁abus", "▁until▁subjects▁have▁access▁to▁commercially▁available▁product▁or▁for▁up▁to▁2▁year s,▁which", "obtain▁the▁consent ▁of▁the▁subject", "ventions▁that▁result▁from▁this▁research.▁Neither▁Amgen ▁nor▁other▁participants▁in▁this▁research▁will▁compensate▁you▁if▁this▁happens", "pensation▁for ▁Injur", "Treatment▁Cycl e-", "ECOG▁45 99", "▁advanced▁esophag o-gastric▁cancer", "▁PD▁=▁progressive▁diseas e;", ",▁Tulsky▁ DS", "echnetium ▁99", "Amgen▁Center ▁Drive▁", "products▁develop ed▁from▁the▁sampl", "condition▁of▁the▁drug ▁and▁enter▁these▁data▁into▁the▁", ",▁Einh orn", "▁my▁records▁ be▁maintained", "s,▁or▁research▁companies▁ may▁patent▁or▁sell", "included▁in▁the▁shipment ▁of▁used▁and▁", "▁of▁panitumumab▁plus▁FOLFIRI ▁on", "▁as▁described▁in▁Appendix ▁1", "▁unblinding▁information .▁This▁", "▁particular▁clinical▁import ance,▁other▁than▁SAEs▁and▁those▁", "▁Dose▁Modification▁Algorithm ▁for", "\n\nAny\n\nYes \n\nPD", "▁the▁development▁of▁commercial▁pharmaceutical▁product s.▁Amgen▁and▁other▁researcher", "ed,▁and▁accurately▁ reported▁according▁to▁the▁protocol", "’s▁institution,▁who▁will ▁check", "▁weekly▁then▁treat▁based▁on ▁interval", ",▁other▁researcher s,▁or▁research▁companies▁may▁patent▁or▁sell", "▁ruler▁or▁c ali", "▁paper▁forms▁will▁be▁ made▁by", ".\n\nHow▁will▁the▁confidentiality▁of ▁my▁records▁be▁maintained", "▁RS,▁Rubin stein▁L", "accountability▁of▁all ▁us", "ies▁must▁be▁made▁available▁for ▁inspection", "▁PET▁scans▁or▁s keletal▁surveys", "anders▁J,▁Kaplan ▁RS,▁Rubinstein▁L", "sertion▁of▁the▁correction ▁above▁or", "aresthesias/d ysesthesias", "document▁contains▁confidential▁information▁of ▁Amgen▁Inc", "ing▁it▁crit ically▁for", "▁expected▁to▁benefit▁you▁directly▁or▁to▁alter ▁your▁treatment▁course", "▁will▁be▁manufactured▁and▁packag ed▁by▁Amgen▁Inc", "▁AND▁QUALITY▁ASSURA NCE", "▁of▁10▁mM▁Sodium▁Acet ate,▁5%", "▁Manuscripts▁Sub mitted▁to▁Biomedical▁Journal", "ize▁discoveries▁or▁in ventions▁that▁result▁from▁this▁research.▁Neither▁Amgen▁nor▁other▁participants▁in▁this▁research▁will▁compensate▁you▁if▁this▁happens", "ing▁the▁article▁or▁revis ing▁it▁critically▁for", "▁at▁start▁of▁cycle,▁hold▁and▁check ▁weekly▁then▁treat▁based▁on▁interval", "▁Study▁Code:▁D8480C00013▁Version▁No: ▁<>▁Version▁Date:▁<>", "▁particular▁clinical▁importance,▁other▁than▁SAEs▁and▁those▁ AEs▁leading▁to▁discontinuation▁of▁the▁", "▁the▁development▁of▁commercial▁pharmaceutical▁products.▁Amgen▁and▁other▁researcher s▁may▁us", "\" ▁of▁the▁study", "\" sponsor", "% ,▁and▁", "' Inf", "( 25", "( to", "( 14", "( 13", "( i.e.,▁", "( essential", "( EOS", ") ▁of▁", ") ▁M", ") ,▁as▁", ") .▁No", ") \n\nAny▁", ") ▁is▁an", ") ,▁and▁all", ") ▁provided▁that", ", ▁ac", ", ▁adverse▁event", ", 16", ", ▁an▁", ", ▁the▁prior", "- k", "- 11", "- arm", "- 36", "- 75", "- 91", "- enhanc", ". H", ". P", ". ,▁and▁", "/ D", "/ s", "/ d▁", "/ fl", "/ III", "/ 5-FU", "/ ALT", "/ SD", "/ Discomfort", "0 .01", "0 .75", "1 ▁tablespoon", "1 ▁oxaliplatin▁dose▁level", "2 15", "2 -0", "2 1-day▁", "3 ).\n\n", "6 ▁mg/kg", "6 -methylgu", "7 90", "7 ▁days▁prior▁to", "9 00", "9 -5", ": ▁C", ": ▁2", ": 17", ": \n\nH", ": ▁intervention", ": ▁N0147", ": ▁Result", ": ▁Proc", "; 35", "? \n\nA", "? ▁J", "? \n\nThis▁", "A pprov", "A VF2107", "B ax", "B rain", "B ilirubin", "B NP", "C ent", "C RA", "C etuximab", "C andid", "C alcium", "D P", "D a", "E ur", "E MENTS", "E fficacy▁Analys", "F rom", "F FIC", "F ah", "F DG", "G B", "G ,▁G", "H L", "H ▁test", "H ospitalization", "H ematology", "H anna", "I dentification▁Number", "L L", "L ung", "L LN", "M ay▁", "M etastas", "M AT", "N L", "O U", "O ste", "O ▁NOT", "O pen-Label,▁Phase▁3▁Study▁of", "P rofile▁", "Q uestion", "R ev", "R och", "S qu", "T ype▁I", "U LT", "U rea", "V itamin▁B12", "W OG", "W HS", "[ 1]", "] ▁+", "a j", "a ▁l", "a ▁K", "a ▁subject’s▁", "b ain", "b one", "b olus▁", "b ittl", "c at", "c app", "c opy▁", "c apacity", "c ise▁", "c Le", "d -", "d rogen", "d estruction", "d izziness", "e em", "e ign", "e .▁Patients▁", "e .▁These▁", "e what", "e oxy", "f ive▁", "f ixed▁", "f rozen", "f istula", "f ine▁needle▁aspir", "g ast", "g rant", "g astroesophageal▁junction", "h u", "h ▁t", "h al", "h ov", "h epatic", "h e▁or▁sh", "h ives,▁", "i aries", "i ak▁A", "i antonio", "k ine▁", "k -1", "k dr", "m -", "m ild", "m ometer", "n R", "n as", "n utrient", "o ▁per", "o ▁Y", "o ctor", "p ine▁", "p uscular", "p ulse", "p =0.00", "r ur", "r ive▁", "r inc", "s iz", "s \n\nSubject", "s ource▁document", "s ..................................................................................", "s erious,▁", "s ▁the▁specific", "s pecimens", "t )", "v es", "v iven", "v ital", "v 3.", "w rit", "y i", "y ers▁", "y ellow", "z a▁n", "’ ▁button", "“ chronic", "“ symptomatic▁deterioration", "” )", "” ▁if", "▁ —", "▁ ra", "▁ elect", "▁ e▁m", "▁ ________", "▁ eg,▁", "▁ **", "▁ optimal", "▁ role▁in", "▁ routinely▁", "e▁ F", "e▁ d▁", "e▁ one▁", "e▁ are▁", "e▁ model", "in us", "in hibit", "in flamm", "in ▁our", "in -line▁filter", "in vit", "in ▁nature", "at ▁the\n\n", "at ▁the▁tim", "at abas", "at ▁anytim", "at al▁outcom", "at ▁the▁discretion▁of▁the▁treat", "on to", "on ▁baseline▁", "on avir", "\n\n po", "\n\n drug", "\n\n arm", "\n\n level", "\n\n reaction", "\n\n ________________", "\n\n overall▁survival", "\n\n ___", "▁a ▁different", "▁a ▁statistically▁significant", "en al", "en able▁", "er on", "or i", "or s▁of", "or ▁through", "or ▁follow-up", "or ▁within", "or ▁preclinical▁data", "s▁ 9", "s▁ 11", "s▁ is▁not", "s▁ ..........................................................................................", "s▁ ....................................................", "s▁ deemed▁", "s▁ gain", "s▁ vary▁", "re ll", "re as▁", "re ech", "re cord▁of", "re veal", "▁th reatening", "▁th ymidylate▁synth", "al ang", "al ong", "st ay▁", "st able", "it re", "it e▁for", "▁the▁ current", "▁the▁ follow-up", "▁the▁ randomization", "▁the▁ original▁", "▁the▁ blinded▁treatment▁phas", "an e▁", "an ▁D", "an ▁G", "an y▁of", "an alogu", "an ▁immediate▁hazard", "an algesia", ",▁ study▁", ",▁ In", ",▁ 40", ",▁ drug", ",▁ NC", ",▁ under", ",▁ study▁treatment", ",▁ due▁to", ",▁ high", ",▁ wher", ",▁ what", ",▁ erlotinib", ",▁ such▁as", ",▁ especially▁", ",▁ glucos", ",▁ fatigue,▁", ",▁ representative▁of▁all▁involved▁organ", ",▁ 2▁weeks▁off", "ed▁ no", "ed▁ disease▁", "▁an ▁assessment▁of", "▁an ▁important", "▁an imal▁", "ic o", "................ ....", ".▁ p", ".▁ d▁", ".▁ INTRODUCTION", "ed -up", "ed .\n\nS", "ed ,▁as▁", "ed .▁Patients▁with", "▁p age", "▁p alli", "▁p ush", "▁p ackag", "▁c it", "▁c ovariates", "ing ▁M", "ing ▁hormone▁", "ing ▁cause▁of", "▁b id", "▁b i-", "▁b icalutamide▁", "▁b arrier", "▁b olus", "▁b eside▁the▁error", "es .▁If", "es \n\nThe▁", "es e▁data", "es \n\nof", "ation ▁from", "▁to ▁placebo", "▁to ▁compar", "▁to ▁withdraw", "▁to ▁Treatment", "▁to ▁the▁sponsor", "▁to ▁conduct", "▁to ▁50", "▁to ▁take▁", "▁to ▁reduc", "▁to ▁determine▁", "▁to ▁creatinine▁", "▁to ▁control", "▁to ▁evaluate▁", "▁to ▁follow▁up", "▁to ▁determine▁whether", "▁to ▁measure▁", "▁to ▁provide▁a", "▁to ▁0.9", "▁to ▁characterize▁the▁objective▁tumor▁respons", "▁to ▁attest▁that", "is -", "is ▁assum", "▁s ens", "▁s low", "▁s ince▁the▁treatment▁start", "▁s era", "as es▁of", "as ed▁upon", "▁of ▁ABX-EGF", "▁of ▁protein", "▁of ▁malignanc", "▁of ▁chest,▁abdomen", "▁d ress", "▁d ella", "▁d iction", "▁d egrad", "th ▁subject", "th ey▁", "▁m uch", "▁m argin", "▁m ioc", "▁and▁ 2", "▁and▁ 9", "▁and▁ 12", "▁and▁ report", "▁and▁ 36", "▁and▁ Appendix", "▁and▁ maintain", "▁and▁ zoledronic▁acid▁", "▁and▁ fatigu", "▁and▁ ANC", "▁and▁ KRAS▁mutation", "▁and▁ colleagu", "▁and▁ 0.22-micron", ".\n\n Z", ".\n\n f", ".\n\n h", ".\n\n Clinical▁", ".\n\n Withdrawal▁of", "ill ip", "al▁ infection", "al▁ Therapy", "el ▁L", "ol ar", "ol ac", "ab normal▁", "ab solute▁", "is▁ with", "is▁ performed", "is▁ restricted▁to", "iv e▁t", "iv e▁to", "iv e-", "iv ari", "iv otal", "▁in ▁W", "▁in ▁clinical▁trial", "▁in ▁any▁other", "▁in ▁patients▁receiving", "▁in ventor", "▁in surance▁", "im eter", "im balanc", "im onthly▁", "ev olv", "res s▁s", "ig in", "ig rad", "00 9", "id ence▁", "oc abul", "oc ally▁Ad", "▁1 ,", "▁1 12", "▁1 -year", "▁C ).\n\n", "▁C ardi", "▁C ediranib", "▁C alcium", "▁C LINICAL", "os s▁of", "es▁ C", "es▁ during", "▁P leas", "▁P rednisone▁", "▁P ost-Study▁", "pro c", "pro p", "il uent", "▁( “", "▁( 200", "▁( 16", "▁( plac", "▁( US", "▁( 3)", "▁( CTCAE", "▁( test", "▁( Grade▁3", "▁( FOLFIRI", "▁( include▁", "▁( femal", "▁( limited▁to", "▁( ie,", "em ic", "em ur", "em al▁A", "▁2 .2.2", "▁2 ▁x▁ULN", "▁2 50▁mg/m2", "us ed▁or", "ul man", "con vert", "con struct", "con nect", "anc e▁that", "if er", "if ▁not", "▁S L", "▁S op", "▁S pecific", "▁S OC", "▁S ee▁Section", "▁I P", "▁I gG", "▁re test", "▁re appear", "ot or", "ot ny▁", "un controlled▁", "un adjusted▁HR", "un born▁bab", "▁D ,▁B", "▁h old▁", "▁l ev", "▁l iqu", "▁l ength", "e▁of ▁the▁s", "e▁of ▁principal▁investigator", "▁E th", "▁E lig", "▁E ffusion", "▁f ile▁", "▁f resh", "ver y▁s", "ch er", "ch ill", "▁or ▁G", "▁or ▁may▁", "▁or ▁consent", "▁or ▁commercial", "▁or ▁NO", "▁or ▁matching▁placebo", "e▁t ell", "e▁t empor", "ir radiation", "ut ero", "ut aneous▁", "ys phagia", "form yltransfer", "\n\nP eri", "\n\nP regnancy▁", "\n\nP emetrexed▁H3E-MC-JMHR", "iz ed,▁", "iz ed▁c", "iz ed▁tomograph", "ex hibit", "ex cipient", "ex press▁", "qu iv", "ec itumumab", "▁n utritional▁", "▁n arratives▁of", "per ▁the▁", "\n\nA s", "\n\nA ▁copy▁of", "\n\nA ▁X▁D", "ate▁ if", "study▁ site▁", "▁and ▁also", "▁and ▁administration▁of", "▁O ▁N", "▁O ME", "▁as ▁the▁independent", "▁pro ven", "▁pro phylactic", "all ic", "all el-", "▁T 4", "▁T echnetium▁99", "up set", "▁N 1", "▁N A", "▁N /A", "▁N SAID", "vestig ation▁of", "op apular", "will▁be▁ performed▁at", "will▁be▁ kept", "ast iere▁", "▁for ▁patient", "▁for ▁subjects▁with", "▁for ▁specific", "▁for ▁further▁detail", "▁for ▁any▁other▁reason", "and ▁after", "and ▁then", "▁R D", "▁R ash", "▁R equisition▁Form", "e\n\n 2", "▁treatment ▁given", "▁treatment ▁rest", "▁treatment ▁regimens", "▁treatment -by-", "▁treatment ▁administered▁for", "study ,▁a", "ed▁to xicity▁", "ed▁to ▁ensure▁that", ".1 .\n\nStudy▁", "og astric", ".2 .7", "▁with ▁other", "▁with ▁respect▁to", "▁with ▁the▁longest▁diameter", "ed▁b ecause▁of", "min otransfer", "s▁of ▁tumor", "s▁of ▁CYP3A4", "s▁of ▁the▁target▁lesion", "s▁of ▁the▁dispens", "be▁ readily", "ant a", "ant s▁of", "\n\nS et", "\n\nS urvival", "\n\nS ummary▁of", "▁that ▁persist", "▁200 5)", "▁is▁ conduct", "▁is▁ stopp", "▁is▁ expos", "▁is▁ found▁to", "▁is▁ hypothesiz", "▁is▁ strongly▁encouraged▁to", "▁is▁ unique▁to▁the▁individual", "▁will▁be▁ considered▁", "▁will▁be▁ allow", "▁will▁be▁ used", "▁will▁be▁ mail", "▁will▁be▁ included▁in▁the▁", "▁will▁be▁ censored▁on", "▁will▁be▁ left▁to", "e▁s unitinib", "e▁s equ", "e▁s ubsequent", "eri ous▁infusion", "art in", "e▁th en", "e▁th e▁treatment", "▁M en", "▁M etastas", "▁M MR", "▁M SS", "▁r hin", "▁0 .4", "▁3 .3.2", "▁3 2:", "▁3 .3.3", "▁con cerning", "ust hov", "e,▁ it", "e,▁ patients▁", "e,▁ platelet", "e,▁ i.e.,▁", "e,▁ incidence,▁", "▁o xy", "▁o ▁x▁ic▁", "▁F IG", "▁F emal", "▁F leming", ".▁A ▁recent", ".▁A ▁second▁", ".▁The▁ result", ".▁The▁ analysis▁", ".▁The▁ DMC", ".▁The▁ use▁of", ".▁The▁ monitor", ".▁The▁ IEC/IRB", "▁as▁ required", "▁g ender", "▁g lobal▁", "not ▁consent", "not ▁experienc", "not ▁been", "not ▁meeting", "as▁ defined▁in▁Section", "01 )", "▁the▁s can", "▁the▁s oftware’s▁“audit▁trail”", "▁are▁ protein", "▁are▁ described▁in▁Section", "▁on ▁the▁s", "▁on ▁active▁treatment▁than▁on▁placebo", ",▁and▁ Amgen", "rad ycardia", "ated▁ study▁", "ated▁ from", "ated▁ with▁the▁", "ition ▁of▁the▁", "▁L ett", "▁B iol", "▁B ased▁on▁the▁", "▁B AP", "ific ance▁of", "▁this▁ question", "▁this▁ confidential▁information", "s,▁ 200", "s,▁ other▁than", "s,▁ including▁the▁", "s,▁ method", "s,▁ lymphocyt", "s,▁ laboratory▁and▁", "▁y es▁", "▁y ellow", "▁all ▁data", "▁all ▁study▁drug", "▁all ▁patients▁who", "▁all ▁samples▁", "▁all ▁sites▁of▁disease▁", "ary▁ lesion", "12 -month", "▁analys es▁in", "▁st ruct", "\n\nC LINICAL", "▁ch emon", "▁ch imeric", "▁will ▁follow", "▁will ▁comply▁with", "▁will ▁employ", "▁will ▁correct", "e▁in ▁a", "e▁in jection", "e▁in strument", "▁5 .2.1", "▁5 .1.1", "▁5 .2.2", "▁6 ▁to", "▁6 .1.3", "from ▁other", "▁H M", "▁H igh", "▁H ospitalization", "▁subject ▁confidentiality▁", "▁patients▁ for", "▁4 47", "▁4 .3.2", "ew art", ")\n\n 3", ")\n\n T", ")\n\n With", ")\n\n (X", "▁at ▁your", "▁at ▁the▁investigator’s▁discretion", "▁at ▁immediate▁risk▁of▁death", "ay bittl", "ampl e▁Siz", "s▁( 2", "s▁( C", "s▁( G", "▁ac knowledg", "▁ac compani", "▁ac ne-", "eg ,▁p", "▁study▁ document", "▁study▁ requirement", "▁study▁ observation", "continu ed", "continu e▁on", "ident ity▁of▁investigational▁product", "lo ia", "s▁in ▁addition▁to", "s▁in ▁women▁with", ".5 5", "s.▁ (", "▁week ▁of▁rest", "ens ure▁", "ens e▁or", "rit onavir", "▁any▁ clinical", "▁any▁ remaining", "▁any▁ component", "▁V ery▁", "▁the▁t ransfer", "▁the▁t ablet", "ell 'Inf", "▁wh ite▁", "\n\nD ocetaxel", "ed▁by \n\n", "ed▁by ▁the\n\n", "ed▁by ▁treatment▁arm", "urv ey", "▁after ▁pemetrex", "▁after ▁carboplatin", "▁after ▁discontinuation▁of▁treatment", "ed▁for ▁consist", "ed▁on ▁an", "19 8", "e▁d etermin", "e▁d ate▁of", "e▁d epend", "e▁d esign", "e▁d escription", "e▁d o▁not", "e▁d oes▁not", ".▁S ch", ".▁S urvival", ".▁S ingle-", ".0 ▁month", "ob vious▁", "▁patient s.▁S", "s▁will▁be▁ collect", "s▁will▁be▁ administer", "s▁will▁be▁ conduct", "▁have▁ caus", "▁have▁ access", "▁G emcitabin", "▁un desirable▁medical▁condition", "▁un willing▁or▁unable▁to▁comply▁with", "ard ico", "▁e jection", "▁e -mail", "▁J ,▁L", "ov ind", "▁tim ing,▁s", "AE s,▁", ".▁P oly", ".▁P articipant", ".▁P lacebo", "\n\nE astern▁Cooperative▁Oncology▁Group", "\n\nE stimated▁Study▁Duration", "\n\nE fficacy▁and▁pharmacodynamic", "),▁ will▁be▁", "▁ant im", "▁from ▁study▁", "s\n\n R", "s\n\n T", "s\n\n [", "s\n\n .▁T▁N▁E▁M▁U▁C▁O▁D", "s\n\n New", "s\n\n Y▁P▁O▁C", "evalu ation▁of▁the▁study", "▁is ▁a▁s", "▁is ▁appropriate▁", "▁not ▁indicated", "▁tumor ▁model", "▁may▁ withdraw", "s▁for ▁verification", "ement s▁should▁", "▁7 )", "▁7 .9", "▁7 ▁days▁", "su persed", "▁month s▁from", "▁month s▁in▁the▁", "▁dos e,", "▁dos es▁(", "▁dos es▁are▁", "▁dos es,", "ction ▁to▁be▁", "effect ▁is▁", "CT D", ",▁the▁ use▁of", "e- adjusted▁", "▁adverse▁event s", "▁adverse▁event s▁were▁", "vid ence▁", "▁per ▁mL", "e▁v alid", "e▁v ocabul", "str at", "▁10 .5.1", "▁10 .5.2", "▁10 .▁STATISTICAL▁CONSIDERATIONS", "ibl e▁method", ".6 .4", "can s▁were▁not▁performed▁at▁this▁time▁point", ".▁In dividual", ".▁E THICS", ".▁E thical▁Review", "▁assessment s▁for", "record ed▁from", "record s▁from", "s.\n\n B", "s.\n\n 11", "s.\n\n C▁I▁N▁O▁R▁T▁C▁E▁L▁E", "RA NCE", ",▁and ▁their", ",▁and ▁any▁other", ".▁C ell", ".▁C alcium", ".▁C reatinine▁Clear", "11 7", "▁sign ▁of", "▁sign alling", "AL P", "40 ▁–▁ag", "peri pheral▁neuropath", "par s", "drug ?", "drug ▁administration", "drug ▁storage▁", "drug ▁accountability", "drug s▁taken▁in▁combination▁with", ",▁or ▁both", ",▁or ▁if▁you", "CR \n\n", "ed▁at ▁the▁end▁of", "▁in▁the▁ event", "▁in▁the▁ eCRF", "ym pos", "ym met", "radi oisotop", "e.\n\n 11", "▁disease▁ fre", "): ▁a", "yp ed▁or", "▁9 .0", "\n\nX\n\nX \n\nX▁X", ".,▁ K", ".,▁ W", "▁8 .5.1", "▁8 .12", "e▁( S", "e▁( including", "first ▁day▁of", "▁us ed▁", "▁us ed▁in▁this▁study", "▁us ed▁in▁combination▁with", "▁us e▁vocabul", "\n\nProduct: ▁ABX-EGF▁Protocol▁Number:▁20020408▁Amendment▁4▁Date:▁26▁April▁2005\n\nPage▁", "\n\nN 1", "e▁for ▁completion", "he it", "ran ial▁", "30 ▁and▁M", "▁data ▁record", "▁data ▁received▁at", "▁data )▁provided▁that", "every▁ other", "every▁ week", "every▁ 32", "every▁ 21▁days", "▁trial s▁in", "▁trial ▁compar", "▁trial ▁material", "▁trial ▁comparing", ".7 9", "arm Dx", "\n\n2 \n\nAmbulatory▁and▁capable▁of▁all▁s", "▁should▁be▁ withheld▁", "▁should▁be▁ signed▁and▁personally▁dat", "▁should▁be▁ prepared▁in", "earch ▁for", "▁other s?", "ne quiv", "▁the▁investigator ▁will", "▁the▁investigator ▁wish▁to▁assign▁the▁study▁records▁to", "subject s▁will▁be▁", "subject ▁who", "subject s”", "▁your ▁current", "Study▁ Plan", "ind ler", "NC IC", "▁- 20°C", "▁to▁be▁ used▁at", "▁pre clinical", "▁pre cision", "ed▁as▁ having", "24 00", "24 ▁week", "24 -hour", "▁has▁ demonstrated", "▁Study▁ Endpoints", "▁Study▁ Candid", "des pit", "▁a▁s econd", "▁a▁s pecial", "▁a▁s olit", "\n\nF ax", "▁cycl e.▁", "present ▁at▁the▁", "present ▁and▁no", "14 ▁days", "\n\nT 1", "\n\nT arget", "e, ▁their▁spous", "\n\n3 3", "\n\n3 5", "\n\n3 .\n\nEXPERIMENTAL▁PLAN", "000 ▁µg", "▁im plication", "▁im partial", "protocol ▁signature▁p", "▁the▁patient ’s", "ed,▁ double-blind", "▁The▁ primary", "▁follow ▁a", "▁follow ing▁", "ification ▁of▁the▁", ".▁D epending▁on", ".▁D uration▁of", "▁the▁l arg", "▁the▁l aboratory", "▁the▁l iver", "▁the▁l umbar▁spine▁", "▁the▁l og-rank▁test", "ST S/", "no ▁prior", "s▁are▁ original", "s▁are▁ no▁longer", "▁dose▁ (mg)▁=", "▁reg ister", "y,▁ is▁", "y,▁ including▁a▁ruler▁to▁estimate▁the▁size▁of▁the▁lesion", "complet e,▁and▁", "complet ed▁within", "pr iv", ".\n\nA c", ".\n\nA ▁subject", "▁ob es", "▁ob viously▁", "efficac i", "\n\nThe▁ first", "\n\nThe▁ study▁will", "▁toxic ity▁of", "\n\n4 .7.1", ".▁F ever", "ically▁ Significant", "data ▁will▁not▁be▁", "data ▁collection", "e▁b owel", "e▁b ody▁", "5- 10", "require s▁in-", "unit ▁errors▁(", "s▁that ▁may▁be▁", "23 ▁2", "23 .5", "23 -3", "\n\nI ▁worry", ",▁S ug", ",▁S imon", ",▁S ien", "▁panitumumab ▁infusion", "defin ed▁in▁the▁", "s▁or ▁inspection", "s▁or ▁retest", "ymptom s▁of", "car e▁of▁the▁patient", "es,▁ if", "es,▁ it▁is▁", "▁car ri", "▁car bon", "▁was▁ 10", "▁was▁ given", "▁was▁ freely▁", "▁Clinical▁ Trial▁", "in▁the▁ CRF", "in▁the▁ case▁report▁form", "▁death s▁occurring", ".\n\nS IGNATURES", ")▁ ×", "e▁treatment ▁at", "5% ▁significance▁level", "must▁be▁ complet", "must▁be▁ taken", "must▁be▁ done▁", "199 0;", "dos e", "dos e,▁", "patients▁ must▁be▁", "SC CHN", "e▁and▁ blood▁", "provid es▁", "provid ed\n\n", "urvival▁ in", "rough t", "ed▁and▁ be▁readily", "▁di astolic", "▁An ▁independent", "▁An drogen", "▁the▁study▁ will▁be▁", "▁the▁study▁ will", "▁the▁study▁ investigator", "▁the▁study▁ may▁be▁", "▁the▁study▁ site▁personnel", "▁includ ing▁the▁", "may▁be▁ judged▁to▁be▁due▁to", "may▁be▁ asked▁to▁sign", "▁must▁be▁ confirm", "▁must▁be▁ reported▁to", "s: ▁", "▁infusion al▁5-fluorouracil", "▁infusion ▁set-up", "ox ▁model", "enter ed", "enter ed▁in", ".▁R isk", ".▁R EG", "▁sit es▁(", "▁sit e▁facil", "▁sit e▁initi", "enroll ed▁to", "consider ed▁by▁the▁investigator▁to▁be▁", "\n\n0 .8", "\n\n0 \n\nFully▁active,▁able▁to▁carry▁on", "▁year ly▁", "▁year s▁after▁the▁last", "▁the▁subject ▁signs", "▁the▁subject ▁does▁not▁wish▁to", "Investigator ▁must", "▁complet e\n\n", "▁complet e▁description", "\n\nH uman", "▁group ▁sequential", "▁this▁study ▁and▁for", "discontinu ing▁the▁", "▁Com mission", "▁approximately▁ 7", "▁approximately▁ 16", "▁particip ate,▁", "▁discontinu es", "ES P", "ES ▁or▁NO", "randomiz ed\n\n", "randomiz ed▁to▁the▁", "St atistical", "St ratification", "valu e▁in", "document ed▁as▁", "inc e▁treatment▁start", "crib ing", "▁ind welling", "duc ed▁by▁", "ed\n\n from", "ed\n\n by", ".▁B lood", "ish ed▁", "response▁ rate▁of", "▁and/or ▁to", "▁and/or ▁written▁statement", ".8 .▁Treatment▁Compliance▁", "ed▁s hould▁be▁", "\n\nx \n\nPage▁", "▁= ▁sever", "▁= ▁No", "▁= ▁absolute▁neutrophil▁count", "\n\n6 1", "\n\n6 5", ".▁M ethod▁of", ".▁M iller", "▁provid ed▁by▁", ")▁and▁ its▁", ")▁and▁ progression-free▁survival▁(PFS)▁compared▁to", "▁event s▁(", "▁event s:", "cess ive▁", "▁disease▁progression ;", "▁disease▁progression ▁(per", "▁should▁ be▁taken", ",▁s afety,▁", ",▁s evere▁", ",▁s pecify", "loc ated▁and▁destroy", "▁these▁ assessment", "s▁b eyond", ",▁M N▁55", ",▁200 2", "▁sh ock", "elect as", "▁may▁be▁ a", "▁may▁be▁ found▁in▁the▁", ".▁H ow", "▁mor bid", "s▁will ▁include▁a", "cin amide▁ribonucle", "▁must ▁also▁be▁", "▁must ▁agree▁to", "▁loc ally▁", "medication ▁for", "observ ed,", "▁rel ev", "▁(A l", "administer ed▁s", "sub stantial", "▁level s▁and▁", "▁metastatic ▁disease", "▁metastatic ▁and/or▁recurrent", "▁blood▁ count", "▁blood▁ drawn", "▁result ing▁from", "ed▁on▁the▁ eCRF", "ation▁of▁ overall", ".▁An tic", "review ed", "review .▁The▁", "review ▁of▁all", "review ,▁subject", "review ▁of▁study-related▁", "\n\nIn ▁addition▁to", "\n\nIn dependent▁Ethics▁Committee/In", ",▁b one▁", ",▁b ecause▁", "es▁for ▁Standard▁", "▁stat es:", "s, ▁anticip", "s, ▁abstract", "s, ▁this▁study▁may▁be▁", "▁19 97", "▁19 96", "▁19 95", ".▁N ature", "ext raction", "risk ▁and▁", "e▁m easurable▁lesion", "\n\nB lood▁samples▁for", "\n\nB linded▁Treatment", "\n\nB linding▁and▁procedures▁for▁unblinding▁the▁study", "▁by▁ representatives▁from", "▁by▁ color▁photograph", "▁– ▁S", "es▁( e.g", "es▁( leg", "able▁to ▁continu", "▁respons e,", "▁respons ibilities▁", "ograph ical▁", "▁randomization ▁in▁the▁study", "▁[ 11", "end▁of ▁study▁visit", "ull y▁", "▁baseline▁ valu", "▁baseline▁ weight", "▁baseline▁ PSA", "e▁or ▁the▁condition", "urther ▁management", "chang e▁", "chang e▁must▁be▁", "RE IM", "when ▁clinically▁indicated", "when ▁this▁event", "▁ID ▁number", "CAE PR", "were▁ not", "▁document s▁submitt", "ed▁a pprov", "ed▁a s▁of▁the▁data", "▁12 ▁months▁(", "▁12 -lead▁ECG", "was▁ based▁on", "▁the▁treatment ▁period", "▁the▁treatment ▁phase▁of", "eport ing", "▁17 00", "▁17 .0", "blind ing▁at", "▁Clin ically▁significant", ",▁H arris▁", ".000 5", "▁chang e▁from", "each ▁year", "\n\n8 .7", "▁Amgen 's▁", "▁Amgen ▁and▁the▁investigator", "di phenhydramin", "di aries", "di etary▁", "▁ne ed▁for", "▁ne urologic", "ed▁or ▁reviewed▁the▁data", "well ▁as▁", "▁CR /PR", "▁int end", "▁int ention", "\n\nAn ▁Investigational▁Product", "▁OS ▁and/or", "▁agent s▁that", "▁diseas e.▁", "▁diseas e,▁or", "s▁from ▁the▁previous▁", "▁time▁ is▁", "have▁been ▁conduct", "▁approv ed▁method▁of", "▁plus▁ irinotecan", "▁plus▁ cetuximab", "▁plus▁ Carboplatin▁and▁Bevacizumab▁Followed▁by▁Maintenance▁", "▁K D", "▁K nown", "▁K arnofsky▁Scor", "▁study▁drug ▁or", "efficacy▁ evaluation", "▁Y ES▁or▁NO", ".▁I mmun", "assessment ▁of▁", "\n\nApproved\n\nDate▁Printed: ▁13−Aug−2013", "▁medication ▁you▁are▁", "s▁should▁be▁ follow", "▁within ▁42", "▁Pro ject", "▁Pro cedure▁", ".▁Patients▁ should▁", ".▁Patients▁ experiencing", "▁new ly▁diagnos", "just ifi", "▁this▁study▁ with", "▁this▁study▁ must▁be▁", "medi ated", ",▁G old", ",▁G ood▁Clinical▁Practice▁(GCP", "s▁on ly▁", "s▁on ▁study", "visit ing▁the▁investigator", "versus▁ no", "▁has▁been \n\n", "▁has▁been ▁report", ",▁et▁al .▁C", "design ee▁", "io edema", "io ▁della", "▁who \n\n", "▁anti- EGFR", "▁anti- hypertensive▁", "▁allow s", "▁allow ▁the▁", "open ed▁vial", ",▁D esch", "determin ed▁on▁the▁", "determin ed▁by▁the▁", "determin ed▁to▁have▁", "▁trans formation", "▁review ▁process", "▁review ▁will▁be▁performed▁", "regnanc y▁(", "within ▁24▁hour", "within ▁4▁weeks▁of", "\n\nY▁P▁O▁C \n\nD▁E▁T▁N▁I▁R▁P", "Com pensation▁for▁Injur", "\n\n5 3", "\n\n5 .2.1", "count ability", "47 0", "▁protocol ▁devi", "\n\nG ood▁Clinical▁Practic", "▁perform ing▁any▁", "▁at▁least ▁28▁days▁after", "▁first ▁study▁drug▁administration", "Un ivers", ",▁L im", ",▁L illy▁or", "\n\nAppendix ▁2", "\n\nAppendix ▁K", "ummar is", "s,▁and▁ will▁be▁", "▁the▁first ▁infusion", "▁the▁first ▁analysis", "▁the▁first ▁on-study▁", "analysis▁ may", ",▁p articular", "▁cetuximab ▁treatment", "▁cetuximab ▁in▁combination▁with", "Cancer ▁Treatment▁Group", "ify ing▁", "▁sever ity▁to", "based▁on ▁PFS", "▁+ ▁FOLFOX", "-3 rd", "▁associated▁with ▁the▁use▁of", "vis cer", "vis ed▁informed▁consent", "vis ceral", "assess ed▁using", "ence▁in ▁situ", "▁IV ▁over", "caus e▁", "▁toxicity▁ or", "▁toxicity▁ should▁", "▁toxicity▁ criteria", "▁toxicity▁ grad", "▁toxicity▁ (G", "ing▁and▁ visiting▁the▁investigator", "required▁ in", "required▁ study", ".▁O ver", "▁clinical▁ or▁preclinical▁data", "carboplatin -paclitaxel", ")▁will▁be▁ summariz", "\n\nO utcom", "\n\nO ste", "▁between ▁the▁treatment▁arm", "after ▁the▁last", "▁pain ▁from", "▁pain ▁severity", "▁pain ▁severity▁", "▁Adverse▁Event s\n\nAll", "y▁or ▁radiotherapy", "▁SAE s▁will▁be▁", "▁mm ▁Hg", "▁bone▁ pain", "▁withdraw s▁from", ",▁in fusion", ",▁in spect", ",▁in ▁the▁investigator’s▁opinion", "at▁least ▁a", "▁survival▁ follow-up", "▁agre e▁to▁be▁", "new ▁year", "person al▁", "\n\nStudy▁ Schedule,▁Protocol", "▁the▁c ircumstanc", "▁Treatment :", "▁the▁end▁of ▁the▁trial", "▁18 .0", "ates ▁a▁significant", "▁and▁s ponsor", "confirm ation▁of", "confirm ing▁that", "▁safety▁ (", "▁safety▁ evaluation", "▁overall ▁5%▁significance▁level", "▁phase▁ will▁be▁", "▁5- year", "▁acid▁ (", "▁significant ▁medical▁", "refer red▁", "▁is▁not ▁required▁for", "blood▁ collection", "y▁s kin", "analys es▁for", "\n\nProtocol ▁amendment", "EGFR ▁expression", "EGFR ▁gene▁copy▁number", "ensitiv ity▁of", "▁thes e▁d", "ics▁ committee", "study▁drug ▁or", "responsible▁for ▁the▁", ",▁W eek", ",▁W anders▁J,▁Kaplan▁RS,▁Rubinstein▁L", ",▁which ▁is", "▁prior▁to ▁administration", "▁prior▁to ▁starting", "es▁to ▁a", ":\n\n o", ":\n\n …", ":\n\n If", ":\n\n ▁", "▁without ▁interruption", "\n\n10 .5", "26 )(cid:", "Pro gram", "SI B", "▁the▁following :\n\n\n\n", "▁the▁following ▁exception", "used▁for ▁sensitivity▁analyses▁of", ",▁if ▁applicable▁", "▁an▁ opportunity▁to", "ing▁ entries▁", ".▁L ocal▁", "▁prior ▁written▁agreement", "▁or▁ enter", "▁or▁ erythema", "bov e▁the▁", "e▁subject s▁in", "▁Grade▁ 0", "▁Grade▁ ≥2", "▁consent ▁for", "29 ]", "29 ▁(week▁5", "▁they▁ develop", "summar ies▁", "post -treatment", "y▁( including", "▁par enteral", "▁par adigm", "\n\nth an", ",▁K aplan", "monitor ▁to▁ensure▁that", "bevacizumab ▁(", "clos e▁to▁the▁", "▁start ▁of▁other", "▁dat es▁of", "avail ability", ",▁199 4", "ised▁ representatives▁of", "\n\nin fection", "▁metastas es,▁", "ability▁ or▁in", "cycl es▁", "cycl es▁of", "cycl e▁(", "e.▁The▁ investigator", "\n\nm g", "This▁ study▁will▁be▁", ",▁d ocetaxel", "being ▁studi", "laboratory▁ for", "▁meet ▁the▁criteria▁for", "▁100 ▁mg", "▁patients ▁achiev", "hemat ological▁", "▁treated▁with ▁no", "▁biomarker s▁of", "▁total ,▁representative▁of▁all▁involved▁organ", "RS EMENTS", ",▁F leming▁TR", "▁amendment ▁3▁–▁dated▁23▁May▁200", "elf care", "\n\na )", "ey er", "ation,▁ suitable▁for", "▁obtain ing", "serum ▁glutamic", "▁with▁the▁ Sponsor", "▁with▁the▁ corresponding", "▁with▁the▁ exception▁of▁the▁", "▁28 ▁days▁befor", "ing,▁ verifying,▁and▁reproducing▁any▁records▁and▁report", "▁are▁not ▁known", "▁are▁not ▁eligibl", "e; \n\nDrug", "▁(C NS)", "▁Report ▁form", "agent ▁is▁", "plann ed▁interim", "▁are as▁", "ed▁m y▁", "ed▁m ean", "standard▁ operating", "whether ▁the▁", "phase▁ 1", "▁≥ 1", "e▁P ersonal▁", "ren g", "ren heit", "▁Subject ’s▁", "▁Subject s\n\nP", "▁Subject ▁Confidentiality▁", "e▁tumor ▁lesion", ".0▁Approved▁by \n\nApproved", "3- 7", "3- only▁", ".\n\n7 .4", "60 ▁mg/m2", "60 -minute▁infusion", "▁the▁f ac", "▁the▁f urther▁management", "appropriate▁ care▁of▁the▁patient", "▁trial▁ is▁", "CTCAE v3.", "▁consider ed▁to▁be▁", "UN I", "sit es,▁a", "year ly▁", "▁tumour ▁growth", ".▁It ▁has", "▁skin ▁lesion", "▁skin -related▁toxicities▁", "▁can▁be▁ assess", ",▁you ▁should▁notify▁your▁doctor", "therapy▁ in", "up▁to ▁4", "efficacy ▁analyses", "efficacy ▁analyses▁will▁be▁", "ing▁of▁the▁ wor", "variabl es▁(", "on▁the▁ basis▁of", "on▁the▁ adverse▁event▁case▁report▁form", "▁only▁ one▁", "▁the▁data ▁analysis▁", "▁the▁data ;▁and", "experienc ed", "experienc ing▁on", "atur e▁of▁the▁", "ourn igand▁", "▁Grade▁3 /4", "87 ;", "rang e)", "s,▁and ▁their▁spous", "s▁were▁ observ", "▁but ▁is▁", "ITT ▁principl", "\n\nd ay", "▁Safety▁ Monitoring", ".\n\nB ACKGROUND▁AND▁RATIONALE", "used▁ consistent", "AR TIC", "AR FT", "▁a▁p otent", "▁a▁p -valu", "00▁mg/m2 /day▁", "ok es▁", "▁such ▁a▁c", "▁man ag", "FOLFOX )▁will", "censor ing", "high light", "Ther asse▁et▁al", "▁subjects▁who ▁are▁", "▁subjects▁who ▁have▁a", ",▁all ▁original▁source▁document", "▁Response▁ (", ",▁E thical▁Review", "▁supplement al▁vitamin▁D", "maintain ed▁and▁be▁readily", "increas e▁of", "ing▁in to", "▁Dose▁ Selection", ",▁an other", "dec rease▁", "staff ▁are▁responsible▁for", "▁before▁ progression", "need ed▁for▁the▁", "▁individual ▁box", "▁local▁ laboratory▁", "Med ical", "es▁that ▁may▁be▁", "curr ence,▁", "▁different iation", "direct ed▁in▁the▁Laboratory▁", "plus▁ bevacizumab", "emerg ency▁s", "sol ubl", "▁target ▁or▁non-", "▁To ▁investigate▁potential▁biomarker▁development", "▁demonstr ated▁in", "ock roft", "e▁the▁s afety", "▁any▁other ▁systemic▁anti-tumor", "list ed.\n\n", "list ed▁below", "health ▁care▁", "health -related▁quality▁of▁lif", "▁up▁to ▁3", "▁known ▁response▁to", "urin alysis", "▁the▁safety▁ follow-up", "▁chest ▁x-ray▁", "▁my▁ friend", "stitutional▁ review▁board▁(", "sk a", "\n\nTable▁ S130", "▁temper atures", "▁(P LT▁<", "▁reduc ing", "▁reduc e▁the▁dose▁by▁1▁level", ".▁At ▁least", "Ob servation", ",▁h e▁or▁sh", "▁alone▁ cannot▁be▁", "ate,▁ complete,▁and▁", "\n\nCom pensation", "s▁should▁ be▁t", "▁discontinuation ▁from▁the▁study▁", "▁more▁ about", "▁termin ology", "▁randomis ed,▁double-blind", "period ▁and▁for", "lead er", "ed▁according▁to ▁RECIST", "▁k appa", "▁current ▁and▁should▁", "subjects▁ may▁", "▁applicable▁ regulatory", ",000 ▁men", "\n\n(cid:120) ▁Subject▁incidence▁of", ",▁O s", ",▁O basaju", "EP IC", "rect om", "▁remain ▁on", "e▁data ▁are▁", "ECG s▁should▁be▁", "work ▁at▁hom", "written ▁approval", "written ▁approval▁of▁the▁protocol", "\n\nIf ▁you", "▁a▁subject ▁is▁", "▁throm boplastin", "▁Lesion s▁", "▁Lesion s▁that▁can▁be▁accurately▁measured▁in", "xicity▁ profil", ".▁Con t", "\n\nE▁R▁O▁F▁E▁B\n\nY▁T▁I▁D▁I▁L▁A▁V \n\nS▁T▁I", "▁the▁discretion ▁of▁your", "ase▁( G", "ase▁( ALT", "ase▁( LDH", "▁assess▁ your", ".▁Patient ▁has", "▁control ▁for", ".▁No ▁eras", "mean ing▁of▁the▁wor", "▁ZD4054 ▁studies", "▁in▁patients▁with ▁cancer", "▁blood▁sampl e▁(", "AC S", "AC Y", "frequ ency", "submitt ed,▁", "▁appear ▁to", ",▁the▁investigator ,▁or", ",▁the▁investigator ▁is▁responsible▁for", "▁February▁200 6", "▁on▁the▁ CRF", "▁complete▁ 6▁cycles▁of", "ogenic ▁process", "ardiov asc", "▁based▁on ▁clinical▁or▁preclinical▁data", "sp elling", "▁the▁sit e", "▁the▁sit e▁to", "objective▁ is▁to", "▁among ▁wild-type▁KRAS", ".▁You ▁will▁be▁", ".▁You ▁may▁", "▁AstraZeneca ▁or", "ood man", "s▁ar e▁taken", ".▁Cancer ▁Res", ".▁Cancer ▁Epidemiology,▁Biomarker", "\n\nEx tension", "grad ed▁using", "ert ip", ".▁The▁investigator ▁is▁obligated▁to▁inform", "atas et", "right s▁to", "right ▁now", "al▁or ▁per", "al▁or ▁life-threatening", "▁ext remities", "heart ▁rate", "▁participant s▁will", "sid iaries", "was \n\n", "maximum ▁concentration▁of▁the▁diluted▁solution", "▁written ▁subject", "▁5-FU /leucovorin", "▁serious▁adverse▁event s,▁", "▁laboratory ▁test▁result", "percent ▁change▁from▁baseline▁in▁lumbar▁spine▁BMD", "\n\nFor ▁the▁", "▁requir e▁that", "ott om", "▁Dos ing", "\n\nPatients▁ with", "och ond", "gressive▁disease▁ (PD", "case▁report▁form ▁(CRF", "▁Peri pheral▁neuropathy", "▁Peri pheral▁Neuropath", "regulation s/", "regardless▁of ▁causality", "rok e▁", "ed▁as▁a ▁minimum", ".\n\n4 1", ".3.3 .3", "\n\nCon firm", "sponsor ▁will", "(1 40▁–▁ag", "▁they ▁are▁not", "before▁ randomization", "e.▁A fter", "▁defin itely▁", "▁Tumor ▁Assessment", "▁is▁responsible▁for ▁informing▁the▁", "▁Committe e▁(", "MR▁200048-052 ▁Master▁Subject▁Information▁Sheet▁and▁Informed▁Consent▁Form▁Version▁4.0▁/▁20▁Nov▁2009", "▁enroll ed▁", "propos ed▁informed▁consent▁form", "e▁dos es▁of", "struct ▁patient", "FOLFIRI )▁will", "▁at▁the▁ next", "corpor ates▁", "paclitaxel ▁and▁carboplatin", "▁active▁ in", "unblind ing▁any▁", "unblind ed▁when", "unblind ed▁interim", "▁adverse▁events▁ leading▁to", "........................ .......▁", "▁is▁the▁ \"sponsor", "▁days▁of ▁the▁last", "▁maintain ing", "▁maintain ing▁a▁comprehensive▁", "▁predict ▁disease▁progression", "ource▁document s▁are▁original", "Sign ature", "▁appl ies▁to", "United▁ Kingdom", "fil es▁contain", "immun ohistochemistry▁", "▁label s▁with▁a", "permitt ed▁to", "az dur", "▁Pre vention", ".\n\nTo ▁collect", "remov al▁from", "▁had▁ previously▁", "▁evaluate▁the▁ benefit", "-L ung", "▁fil es▁containing", "efficacy▁of ▁the▁", "▁site▁ staff", "▁site▁ notification", "\n\nX\n\nX\n\nX\n\nX\n\nX\n\nX\n\nX\n\nX \n\nX", "repeated▁ every▁3▁week", "umbar ▁vertebra", "e▁M easures", "e▁M anagement", "TIN IB", "▁decid es▁that", "▁decid ing▁whether", "udit ▁plan", "rag ment", ".▁This ▁approach", "bi ochemical▁", "select ed\n\nfor", ",▁v an", ",▁v itamin▁B12", "▁daily▁ living", "compared▁with ▁placebo", "wher eas", "-sided▁ log-rank▁test", "▁resolv ed▁or", "e▁the▁patient ▁has▁", "▁the▁investigator’s▁ clinical▁judgment", "▁et▁al,▁200 3", "▁by▁the▁ Sponsor", "cod one▁", "dent al▁pro", "intervention ▁indicated▁", "▁siz e▁to", "▁will▁not ▁compensate▁you", "rig or", "ed▁an ▁adverse▁event", "election ▁and▁Timing▁of", "early ▁as▁", "▁the▁pres ence▁or▁absence▁of", "deriv ing", "▁continue▁ until", "▁continue▁ receiving", "▁continue▁ participation▁in▁the▁study", "ater ▁for▁Injection", "▁less▁than ▁or▁equal▁to", "EL OX-", "idin e,▁", "ocal ca", "▁differenc es▁between", "immediately▁ notify▁", "▁and▁E nd▁of", "process ing", "check ed▁for▁consist", "ed▁using▁the▁ log-rank▁test", ",▁al ong", "insert ▁nam", "▁use▁of ▁at▁least▁25%▁for▁a▁duration▁of▁1▁week▁or▁mor", "Dose▁ Modification", "e.▁In ▁the▁", "still ▁on", "▁becom es", "▁material s▁", "▁material ▁must▁be▁submitted▁to▁the▁", "confidential ity▁is▁", "▁respect ▁to▁the▁first", "▁parameter s▁", "▁a▁f ever", "▁Group ▁B", "▁primary▁ solid▁tumor", "▁and▁m ember", "\n\n15 .\n\nAPPENDICES", "reatinine▁clear ance\n\n", "kept ▁current▁and▁should▁", "▁Man ager", "▁Health ▁Status▁", "ABI-007 /carboplatin", "solute▁ Neutrophil", "Rel ated▁to", "e.▁S pecific", "ton ▁D", "▁tub ercul", "ed▁dos e)", "▁(B MI", "▁(B SA)", "▁(B ackground▁", "e▁during▁the▁ study▁", "▁analysis▁will ▁occur▁when", "evidenc ed▁by▁", "umbar▁sp ine,▁total▁hip", "s.▁If ▁results▁of▁the▁trial▁are▁published,▁your▁identity▁will▁remain▁confidential", "currently▁ with", "currently▁ no", "s▁[ CTCAE", "▁of▁all ▁study-related▁", "▁Baseline▁ and▁", "utility▁ bound", "▁major ▁CVD", "▁Cycl es", "oste oporosis", "oste oblast", "observed▁ during▁the▁study▁", "▁3▁week s▁after", "▁volum e▁infusion", "▁volum e,▁platelet", "do▁not ▁have▁", "TT P", "▁low ▁molecular▁weight", "▁feel ing", "▁improvement s▁in", ").▁In ▁the▁event", "TH ER", "▁treated▁ patient", "PC I", "involv ing", "involv ed▁with", "e\n\nC ONFIDENTIAL", "▁antitumor ▁activity▁", "▁antitumor ▁activity▁of", ",6 ,7", "YP 2", "arily▁ withdraw▁from", "▁Onc ology", "▁Onc ology,▁", "▁temperature▁ alarm", "in▁a ▁timely▁manner", "▁future▁ medical▁car", "▁and▁all ▁co/", "s.▁P anitumumab", ".▁Ch est", ",▁I sh", "▁liver ▁metastas", "required▁for ▁a▁best▁response▁of", "fail ed▁", ",▁for ▁a", "▁Wh ol", "change▁in ▁hemoglobin", "▁designe e▁will", "that ▁are▁clearly▁", "▁(2 1-day▁cycl", "s▁(including ,▁if▁applicabl", "ed▁for▁all ▁randomized▁patients▁", "\n\nLY231514 \n\nH3E-MC-JMIG(f)▁Clinical▁Protocol\n\nPage▁", "e▁trial s▁", "\n\nComplet ion▁of", "▁best ▁interest", "ush ing", "s.▁J ▁Clin▁Oncol", "s.▁J ▁Nutr", "▁Reporting ▁Procedures▁for▁All", "▁discussion ▁(not▁necessarily", "ed,▁and▁ stor", "▁of▁C ertain", "▁(E uroQol-5▁Dimension", "▁IRB ▁approval▁of", "▁via ▁the▁", "▁PFS▁event s▁have▁occurred", "▁worsening ▁of▁a▁pre-existing", "esophag ectomy/", "▁a▁2 5%", "error s▁that▁occur", "▁thos e▁subjects▁who", "▁potential ▁side▁effect", "pre- medication", "pre- existing", "▁antibody ▁assay", "▁procedure▁ for", "▁of▁5 .2", "▁45 ▁mL/min", "▁unblind ed▁", "▁the▁patient▁is▁ lost▁to▁follow-up", "▁should \n\nbe▁", "elv e▁", "nual▁ IEC/IRB", "stant ially▁", ",▁st abilization", "progress ing", "▁advers ely", "ated▁for ▁2", "▁associated▁ 95%▁confidence▁interval", "▁oste opor", "▁the▁previous▁ dose▁level", "reported▁as▁ such", "▁preserv e▁", "▁of▁101\n\n090177e18069a3aa\\Approved\\Approved▁On:▁27-Sep-2007▁02:42\n\n1▁4▁:▁5▁0▁7▁0▁0▁2▁-▁g▁u▁A▁-▁1▁3▁\\▁d▁e▁v▁o▁r▁p▁p▁A\n\n\\▁1▁.▁1▁\\\n\n8▁2▁1▁6▁6▁8 ▁6▁0▁0▁0▁0▁0▁1▁0", ",▁this▁ information", "▁CO STS/", "endar ▁Days", "▁2003 0194", "▁study▁ent ry▁and▁", ".▁Al so", "▁evaluate▁th e▁treatment▁effect", "▁the▁final ▁analysis▁of", "▁recover ed▁to", "▁doses▁ ranging▁from", "▁the▁end▁of▁the▁ blinded▁treatment▁phas", "▁the▁end▁of▁the▁ storage▁period", "30-day▁postdiscontinuation ▁visit", "inalization▁date:▁June▁19▁2001,▁Incorporating ▁amendment▁3▁–▁dated▁23▁May▁200", "accur ate,▁complete,▁and▁", "▁PA CCE", "▁the▁investigational ▁drug", "larg e▁cell", "age▁and▁ mode▁of▁administration", "notification ▁to▁Amgen", "appropri ate\n\n", ",▁a▁s erum", "Day▁1 ▁of", "▁urine▁ or▁serum▁pregnancy▁test", "▁blind ed▁investigational▁product", "▁approxim ation", "right▁to ▁discontinu", "▁own ▁health▁state▁today", "ed▁out ▁with▁a▁black", "▁treatment▁is▁ discontinu", "▁relevant ▁clinical", "\n\nMed ian", "eligible▁for ▁the▁study", "Pharmac ology▁", "roc ort", "ation▁is▁ measured▁from▁the▁date▁of▁randomization", "▁(eg ,▁s", "▁important ▁intellectual▁content", "e▁by▁ contact", "withdrawal ▁criteria", "withdrawal s▁due▁to", "BJECTIVES \n\n1.1", "surger y,▁", "urfac e▁A", "▁exce ed", "▁regular ▁basis", "initial ed▁and▁", "comp ound", ".▁Dose▁ escalation", "▁monoclonal ▁antibod", "▁monoclonal ▁antibody", "LQ I", "▁his▁or▁her ▁sit", "International▁ Committee▁of▁Medical▁Journal▁Editor", "▁allergic ▁bronchospasm", "▁Hy pertension", "▁uniqu e▁Personal▁", "▁participation▁in ▁a", "previous▁ SRE▁(", "laborator y,▁", "omer ase▁", "olin ic▁acid", "▁ANC ▁≥", "\n\nArm ▁1:", "e▁should▁ be\n\n", "▁Compli ance", "▁approximately▁30 ▁days▁after", "combination▁of ▁cetuximab", "▁Suppl ▁1:", ".▁Sunitinib /Placebo", ".▁Pre medication", ".▁Pre paration", "radiotherapy▁ or", "▁a▁single▁ line▁strok", "\n\nFollow ing", ".\n\nCONFIDENTIAL ITY", "\n\nAdd▁6 ,7", ".\n\nY▁T▁I▁D▁I▁L▁A▁V \n\nS▁T▁I\n\nK▁C▁E▁H▁C", "volume▁of ▁distribution", "informed▁consent▁form ?", "ed▁with▁a ▁unique▁Personal▁", "primary▁endpoint ▁of", "fatigu e▁(", "▁↓ ▁1", "▁four th", "▁the▁second▁ infusion", "▁48 ▁hours▁after", "▁plac ement", "▁call ed▁", "European ▁Commission", "bod y▁surface▁area", "pemetrex ed▁and▁", "\n\nan ▁investigator", "▁will▁provid e▁the▁sponsor", ".▁Subjects▁ not▁meeting", "▁minim iz", "▁minim ize▁", ".▁Rec eptor", "e▁Size▁ Determination", "▁ensure▁ adequate▁", "▁Assignment ▁to▁Treatment", "00▁IU /", "▁Subjects▁ Undergoing", "▁facil ities▁", "▁for▁all ▁target▁lesions▁will▁be▁calculated▁and▁", "\n\n1\n\n1 \n\n1\n\n1", "\n\n1\n\n1 \n\n2\n\n2\n\n3", "\n\nEnd▁of ▁Study", "ed▁without ▁prior▁written▁agreement", "▁greater▁than ▁1", "regulatory▁author ity", "regulatory▁author ity▁in", "rul ed▁out", "▁intern ational▁", "metab olit", "▁a▁t axan", "recruit ment", "▁lo ▁Stud", "committe e▁(", "10▁mg ▁orally▁", "▁time▁and▁ initial", "birth ▁control", "▁fat al", "▁access ▁the▁IVRS", "radiotherapy ,▁or", "fax ed▁to", "▁audit ▁by▁representatives▁from", "▁Central▁ Cancer▁Treatment▁Group", "▁will▁be▁present ed▁as▁a▁sterile,▁", "ated▁with in▁the▁", "uroto xicity", "▁representative▁ and▁", "▁at▁a▁dose▁of ▁6▁mg/kg", "▁chronic ▁diseas", "radiographic ▁studies", "▁at▁least▁on e▁dose▁of", "▁clear ance▁", "▁twic e▁daily▁", "(eg ,▁a", "▁dist inct", "▁dist al▁radi", "▁Supplement ation", "▁Not e:", "▁Not ification▁of", "▁subjects\n\n with", "▁super ficial▁", "▁super vision", "istration/ Randomization", ",▁U K", "▁injur y▁", "▁and▁then ▁every▁", "▁the▁schedul ed▁", "elf-care ,▁confined▁to▁bed▁or▁chair▁more▁than▁50%▁of▁waking▁hour", "au er", "promis ing", "\n\nAmendment ▁2", "▁10.3 ▁Sample▁Size▁", "atively▁ resected▁", "▁participation ▁in▁the▁", "▁radiographic ▁scan", "itis▁or ▁fib", "Blood▁ Cell", "mix ed▁with", "al▁well -being", ",▁An d", "cho ic", "\n\nDrug ▁Subst", "documentation ▁(see▁Section", "documentation ▁by▁color▁photograph", "mith ▁T", "▁eryth ema", "allowed▁to ▁receive▁", "reconstitut ed▁ABI-007", "▁becomes▁ stabl", "150 /100", ":▁( may▁occur▁between▁1▁and▁9", "rath er", ".▁Un blinding▁at", "▁PJ ,▁M", "▁DR UG", "▁or▁its▁design ee▁", "upd ates▁", "ed▁in▁combination▁with ▁cisplatin", "▁0.01 103", "▁analyses▁for ▁the▁", "▁dose- related", "recorded▁on ▁each", "▁submission ▁to▁the▁", "d▁( excluding", "▁drop -in", "▁hematologic ▁toxicities", ",▁and▁all ▁drug-related▁", "head▁and▁neck ▁cancer", ").▁This▁ will", "Histor y▁", "cip itating", ".\n\nRE G", "▁recurrence▁ or", "▁commun ity", "notifi ed", "prescrib ing▁information", "▁tests▁ needed▁for▁the▁", "▁implement ation▁of▁Addendum▁9", "▁carcinoma▁of▁the▁ colon▁or▁rectum", ",▁t achycardia", "ed▁f rozen", "▁of▁the▁subject .▁Unblinding▁at", "▁as▁defin ed▁by▁the▁", ")\n\nD iscontinu", "▁description ▁of▁the▁event", "Objectives \n\nReplace:", ".▁Pharmac ogenetic", "extension▁lead▁period ▁and▁", "mutant▁KRAS ▁stratum", "commenc ement▁of", ",▁2007 .▁", "▁the▁safety▁follow▁up ▁phase▁of▁the▁study", "followed▁up ▁for", "gether▁with ▁its", "uscl e▁pain", "▁experiment al▁", ".▁Randomization ▁will▁be▁stratifi", "▁has▁been▁shown ▁to", "▁has▁been▁shown ▁to▁be▁", ",▁et▁al.▁Phase▁ I", "calculated ▁as", "▁even ▁after▁discontinuation▁of▁treatment", "steroid al▁Anti-Inflammatory▁Drug", "of▁of ▁receipt", "▁viol ating▁the▁confidentiality▁of▁the▁subject", "reported▁as▁an ▁SAE", "▁association ▁between", "FIC ATION", "\n\nHy pertension", "▁during▁the▁study▁ period▁and▁for", "maintained ▁temperature▁alarm", "protect ed▁from▁light", "▁third▁part ies,▁except", ".M .,▁et▁al.,▁", "▁evidenc e▁suggest", "▁magnesium ▁level", "ribonucle ic▁acid▁", "non-inferior ity", "▁break ing▁the▁", "▁squamous▁cell ▁carcinoma", "▁induction ▁therapy", "explor ed.\n\n", "▁will▁be▁us ed▁as", "e▁subjects▁ may▁be▁", "correspond ence\n\n", "recorded▁in▁the▁ CRF", "radiological▁ review", "radiological▁ imag", "▁data▁are▁ obtained", "interpret ation▁of▁data", "▁received ▁any▁", "▁Phas e", "▁cases▁ where▁", "▁nonhematologic ▁toxicities▁", "baseline▁sum ▁longest▁diameter", "▁Accountability▁ Recor", "mand ator", ",▁other ▁written▁subject", "▁and▁L eukemia", "▁DS MB", "s\n\n4 \n\nCompletely▁disabled.▁Cannot▁carry▁on▁any▁s", "hair ▁los" ] } }