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{ "abstract": "OBJECTIVE\nWe conducted a phase I trial of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, combined with amrubicin, a topoisomerase II inhibitor. The aim was to determine the maximum tolerated dose, the dose-limiting toxicities (DLTs), and the pharmacokinetics of this combinat...
[ { "companynumb": "JP-ASTELLAS-2015US030286", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ERLOTINIB" }, "drugadditional": null, ...
{ "abstract": "Heavy menstrual bleeding is a common condition among women of childbearing age. Although hysterectomy was the usual approach in acute cases in the past, other minimally invasive therapies or pharmacological alternatives, such as the levonorgestrel intrauterine device have shown to be highly effective. ...
[ { "companynumb": "ES-MYLANLABS-2018M1027383", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "LEVONORGESTREL" }, "drugadditional": null, ...
{ "abstract": "Amiodarone-induced pulmonary toxicity (APT) is a severe side effect that can lead to lung fibrosis or fatal respiratory failure. Usually APT occurs during long term therapy after administration of prolonged loading doses or high cumulative doses. We present the case of a 58 year old woman who underwent...
[ { "companynumb": "DE-MYLANLABS-2018M1032495", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugadditional": null, ...
{ "abstract": "Primary resistant Hodgkin lymphoma is an aggressive disease with few treatment options and short survival. Neoplastic cells of classical Hodgkin lymphoma are heavily dependent on microenvironmental stimuli, regularly express PD-L1, and a relevant proportion of relapsed patients is sensitive to blocking...
[ { "companynumb": "AT-BAUSCH-BL-2018-014296", "fulfillexpeditecriteria": "1", "occurcountry": "AT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugadditional": "3", ...
{ "abstract": "BACKGROUND\nIn chronic obstructive pulmonary disease (COPD) patients with acute respiratory failure (ARF), non-invasive ventilation (NIV) is generally recommended and has proven its benefits by reducing endotracheal intubation (ETI) rates, intensive care unit (ICU) admissions, complications, and mortal...
[ { "companynumb": "CH-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-249705", "fulfillexpeditecriteria": "1", "occurcountry": "CH", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "OXAZEPAM" }, "drugad...
{ "abstract": "The renal survival rate of pediatric renal transplant recipients (pRTR) has improved with the use of modern immunosuppressive agents; however, the incidence of post-transplantation viral infection has increased. This study investigated the incidence of BK viremia and BK viral-associated nephropathy (BK...
[ { "companynumb": "JP-PBT-000320", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DACLIZUMAB" }, "drugadditional": "3", "drugadmi...
{ "abstract": "Murine typhus is a flea-borne rickettsiosis caused by Rickettsia typhi. When severe, endothelial dysfunction can lead to acute kidney injury secondary to prerenal azotemia or acute tubular necrosis. Here, we describe an unusual cause of kidney injury during the course of murine typhus-focal segmental g...
[ { "companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP014483", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugadditional":...
{ "abstract": "This report presents the transplantation of two kidneys and the liver from a deceased donor with suspected autoimmune encephalomeningitis (ADEM). Due to an atypical post-transplantation clinical course, the transplanted kidneys were biopsied and this disclosed diffuse large B-cell (DLBC) lymphoma of th...
[ { "companynumb": "PL-SUN PHARMACEUTICAL INDUSTRIES LTD-2015R1-103707", "fulfillexpeditecriteria": "1", "occurcountry": "PL", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "VINCRISTINE" }, "dru...
{ "abstract": "Drug-induced cardiac arrhythmia, especially occurrence of torsade de pointes (TdP), has been a leading cause of attrition and post-approval re-labeling and withdrawal of many drugs. TdP is a multifactorial event, reflecting more than just drug-induced cardiac ion channel inhibition and QT interval prol...
[ { "companynumb": "GB-MYLANLABS-2018M1051425", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, ...
{ "abstract": "BACKGROUND\nPheochromocytoma is a rare endocrine tumor arising from chromaffin cells and having extensive and profound effects on the cardiovascular system by continuously or intermittently releasing catecholamines. The clinical manifestations of pheochromocytoma are diverse, and the typical triad, inc...
[ { "companynumb": "CN-SA-2021SA176286", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugadditional": "3", "drugad...
{ "abstract": "We present a case report of a patient who developed severe reversible cerebral vasoconstriction syndrome, which was worsening despite typical interventional and supportive care. We administered a stellate ganglion block (SGB) and monitored the vasospasm with transcranial Doppler measurements.\n\n\n\nA ...
[ { "companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-295256", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "NIMODIPINE" }, "drug...
{ "abstract": "In a randomized, nonblinded clinical trial, 36 consecutive patients with generalized convulsive status epilepticus were treated with either combination diazepam and phenytoin (DZ/DPH) or phenobarbital (PB). Phenytoin was added to the PB regimen if seizures persisted for 10 minutes after beginning thera...
[ { "companynumb": "US-ROCHE-2323938", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugadditional": "3", "drugadm...
{ "abstract": "BACKGROUND\nAcrometastases of the hand are an unusual sign of lung cancer onset and may often be mistaken for other benign disorders, thus delaying diagnosis and treatment.\nA 58-year-old man presented at the Rheumatology Clinic with a lump in the distal phalanx of the right index finger associated wit...
[ { "companynumb": "RO-SA-2019SA349079", "fulfillexpeditecriteria": "1", "occurcountry": "RO", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DOCETAXEL" }, "drugadditional": "3", "drug...
{ "abstract": "Clonidine has been used to assist opiate detoxification in the past 10 years. This substance is known to have multiple effects on the central nervous system and to cause withdrawal symptoms when stopped abruptly. The combination of these two effects could result in clonidine having a potential for abus...
[ { "companynumb": "CA-PFIZER INC-202101757742", "fulfillexpeditecriteria": "1", "occurcountry": "CA", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugadditional": "3", ...
{ "abstract": "Psychopharmacologic treatments for eating disorders (EDs) remain unclear, particularly for anorexia nervosa. As in attention-deficit hyperactivity disorder, a dopaminergic mechanism has been implicated in EDs, prompting our use of atomoxetine in an 18-year-old woman with anorexia nervosa, binge/purge t...
[ { "companynumb": "US-APOTEX-2021AP045380", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ATOMOXETINE" }, "drugadditional": "3", ...
{ "abstract": "Vertebral osteomyelitis due to Streptococcus viridans following a dental procedure is a rarely reported phenomenon. We discuss the case of a 67-year-old immunocompetent woman who presented with low back pain of 3 weeks duration associated with subjective fever and chills. On admission, the MRI of the l...
[ { "companynumb": "US-LUPIN PHARMACEUTICALS INC.-2016-02930", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "VANCOMYCIN" }, "drugadditiona...
{ "abstract": "Pyroglutamic acidemia is an uncommon metabolic disorder, which is usually diagnosed at early ages. The mechanism of action is thought to be glutathione depletion, and its clinical manifestations consist of hemolytic anemia, mental retardation, ataxia, and chronic metabolic acidosis. However, an acquire...
[ { "companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-296767", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "d...
{ "abstract": "We describe a case of type B insulin resistance syndrome associated with systemic lupus erythematosus (SLE) that was refractory to rituximab and successfully treated with a combination of oral glucocorticoids and cyclosporine. Prior to treatment, insulin resistance was severe, and application of a hype...
[ { "companynumb": "JP-TEVA-621539ISR", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "INSULIN NOS" }, "drugadditional": null, "dr...
{ "abstract": "BACKGROUND Intussusception in adults (AI) accounts for 1% of all cases of bowel obstruction. While pediatric intussusception is well known and almost always idiopathic, an underlying cause is usually found in adults. Indication for surgical treatment and intussusception reduction before resection remai...
[ { "companynumb": "CH-TEVA-2020-CH-1239445", "fulfillexpeditecriteria": "1", "occurcountry": "CH", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": null, ...
{ "abstract": "Opportunistic infection and reactivation of latent infection has been reported with use of monoclonal TNF alpha antibodies used for treatment of severe rheumatoid arthritis. We present a case of peritoneal tuberculosis (TB) causing renal failure secondary to ureteral constriction in a patient who had b...
[ { "companynumb": "US-JNJFOC-20140702178", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugadditional": null, ...
{ "abstract": "Cupriavidus gilardii is a rare cause of human infection. We report a muscular abscess on the right thigh caused by this organism in a renal transplant recipient, who had suffered a septic shock associated with an extensive cellulitis caused by Streptococcus pyogenes. The patient was successfully treate...
[ { "companynumb": "ES-MYLANLABS-2018M1005563", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "MYCOPHENOLIC ACID" }, "drugadditional": "3", ...
{ "abstract": "Denosumab is a fully human antibody to receptor activator of nuclear factor kappa-B ligand (RANKL), and it is administered every 6 months in women with postmenopausal osteoporosis (PMO) at high risk for fracture. Adverse effects of denosumab include musculoskeletal pain, hypercholesterolaemia, symptoma...
[ { "companynumb": "US-AMGEN-USASP2018062371", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROCHLOROTHIAZIDE" }, "drugadditional": nul...
{ "abstract": "BACKGROUND\nDuchenne muscular dystrophy (DMD), which is caused by a mutation/deletion in the dystrophin gene on the X-chromosome, is the most common type of neuromuscular disorder in pediatrics. Skeletal muscle weakness progressively develops in DMD patients and usually leads to respiratory failure in ...
[ { "companynumb": "CN-JUBILANT CADISTA PHARMACEUTICALS-2020JUB00045", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "UNSPECIFIED INGREDIENT" }, ...
{ "abstract": "Although foam sclerotherapy to varicose veins is now a popular treatment because of its high efficacy and safety, some neurologic complications have recently been reported. Presently, the effectiveness and safety of intravenous recombinant tissue-type plasminogen activator therapy to stroke following f...
[ { "companynumb": "JP-MERZ NORTH AMERICA, INC.-17MRZ-00311", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "EZETIMIBE" }, "drugadditional"...
{ "abstract": "BACKGROUND\nTo evaluate the efficacy and toxicity of irinotecan and oxaliplatin plus 5-fluorouracil (FU) and leucovorin (FOLFIRINOX) as second-line therapy in metastatic pancreatic adenocarcinoma (MPA).\n\n\nMETHODS\nWe retrospectively analyzed the medical records of 27 patients with MPA treated with F...
[ { "companynumb": "FR-CIPLA LTD.-2016FR08930", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugadditional": "3", ...
{ "abstract": "Fungal infections have an important role in organ transplant recipients, and in some cases can be lethal. Blastomycosis is rare in kidney transplantation. We present a case of cutaneous blastomycosis in a kidney transplant recipient in Tunisia, a country outside the known endemic countries. This case, ...
[ { "companynumb": "TN-ALKEM LABORATORIES LIMITED-TN-ALKEM-2018-04371", "fulfillexpeditecriteria": "1", "occurcountry": "TN", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, ...
{ "abstract": "To examine indications for, duration of use, and rate of adverse drug events (ADE) attributable to anticonvulsant initiation, as adjudicated by expert review of electronic health records (EHR) of older adults.\n\n\n\nWe identified a cohort of community dwelling Medicare beneficiaries with linked EHR (a...
[ { "companynumb": "US-UCBSA-2020041841", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugadditional": "3", ...
{ "abstract": "Liver transplant is now considered to be a successful treatment modality for early hepatocellular carcinoma. In addition, advances in immunosuppressive therapy have greatly prolonged posttransplant survival of patients with hepatocellular carcinoma. However, both the posttransplant physiologic conditio...
[ { "companynumb": "TW-MYLANLABS-2016M1053006", "fulfillexpeditecriteria": "1", "occurcountry": "TW", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": "3", ...
{ "abstract": "OBJECTIVE\nTo investigate the efficacy and toxicity of bortezomib of different doses in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma (MM).\n\n\nMETHODS\n23 patients with relapsed or refractory MM, 10 males and 13 females, aged 65 (42-86), were randomized t...
[ { "companynumb": "CN-TAKEDA-2016MPI007723", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "BORTEZOMIB" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nWhen opportunistic infections occur, patients with inflammatory bowel disease (IBD) commonly display a significantly increased rate of morbidity and mortality. With increasing use of immunosuppressive agents and biological agents, opportunistic infections are becoming a hot topic in the per...
[ { "companynumb": "CN-JNJFOC-20190615785", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "MESALAMINE" }, "drugadditional": "3", "...
{ "abstract": "The authors present three cases of carbon monoxide poisoning (two suicides and one accident) from the autopsy material of the Institute of Legal Medicine at Basel, which are unusual with regard to the circumstances at the scene of death, the method of suicide and the post-mortem findings: Suicide of a ...
[ { "companynumb": "CH-ACTAVIS-2014-22052", "fulfillexpeditecriteria": "1", "occurcountry": "CH", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nIt has been reported that tri-weekly Abraxane therapy has better outcomes in recurrent breast cancer than tri-weekly Cremophor-based taxol therapy, and that cyclophosphamide combined with taxane shows an enhanced antitumor effect. We conducted a phase II clinical trial of preoperative chemo...
[ { "companynumb": "JP-CELGENE-087-21660-14081644", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugadditional": null, ...
{ "abstract": "We present a case report of a patient with diffuse skin and systemic Kaposi's sarcoma (KS), 1 year after renal transplantation. A concomitant Pyrenochaeta romeroi granuloma of the right hallux was diagnosed and illustrated an important immunodysfunction in our patient. Four months after reduction in im...
[ { "companynumb": "BE-ACCORD-037360", "fulfillexpeditecriteria": "1", "occurcountry": "BE", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "BISOPROLOL" }, "drugadditional": null, "dru...
{ "abstract": "Fingolimod is an oral sphingosine-1-phosphate receptor modulator which causes lymphocyte sequestration in lymph nodes and is approved for relapsing multiple sclerosis. The Therapeutic Goods Administration of Australia is aware of only one case where fingolimod preceded immune thrombocytopenic purpura (...
[ { "companynumb": "AU-CONCORDIA PHARMACEUTICALS INC.-E2B_00009029", "fulfillexpeditecriteria": "1", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "FINGOLIMOD" }, "drugadd...
{ "abstract": "OBJECTIVE\nTrastuzumab-emtansine is an antibody-drug conjugate developed to decrease off-target toxicity. According to the product label, reactions secondary to extravasation are mild or moderate.\n\n\nMETHODS\nWe report on a 51-year-old woman who developed epidermal necrosis after extravasation of tra...
[ { "companynumb": "NL-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-255213", "fulfillexpeditecriteria": "1", "occurcountry": "NL", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LAPATINIB" }, "druga...
{ "abstract": "Pancreatic cancer is one of the most lethal cancers. To improve its prognosis, conversion surgery for initially unresectable advanced pancreatic cancer (UAPC) after chemotherapy has been reported in recent years.\n\n\nMETHODS\nA retrospective analysis of the patients with initially UAPC underwent conve...
[ { "companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2021RR-318640", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "IRINOTECAN" }, "drug...
{ "abstract": "BACKGROUND\nAmyloidosis and fibrillary glomerulonephritis (FGN) share similar electron microscopic signatures including random arrangement of fibrils. However, distinction between the 2 can often be made using Congo Red staining.\nHere we describe a unique case of FGN, which stained positive for Congo ...
[ { "companynumb": "US-STRIDES ARCOLAB LIMITED-2020SP009730", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugadditional...
{ "abstract": "The management of human epidermal growth factor receptor 2 (HER2)-positive breast cancer has changed dramatically with the introduction and widespread use of HER2-targeted therapies. There is, however, relatively limited real-world information about the effectiveness and safety of trastuzumab emtansine...
[ { "companynumb": "HK-ROCHE-2073134", "fulfillexpeditecriteria": "1", "occurcountry": "HK", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ADO-TRASTUZUMAB EMTANSINE" }, "drugadditional": "3", ...
{ "abstract": "Here, we present possible death caused by Mycobacterium gordonae infection in a patient with angioimmunoblastic T-cell lymphoma. Our patient was severely immunocompromised in whom we suspect to an infection, but we did not have isolates until she died. After she died, we received a positive sputum cult...
[ { "companynumb": "HR-ALVOGEN-2017-ALVOGEN-093437", "fulfillexpeditecriteria": "1", "occurcountry": "HR", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugadditional": n...
{ "abstract": "Imatinib, which inhibits tyrosine kinase activity of Bcr-Abl protein, is a standard form of treatment for chronic myeloid leukemia (CML). Through its immunomodulatory effect it affects T cell function in a number of ways. It inhibits antigen-induced T cell activation and proliferation. Antigen-specific...
[ { "companynumb": "IN-SHILPA MEDICARE LIMITED-SML-IN-2021-00059", "fulfillexpeditecriteria": "1", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "IMATINIB" }, "drugaddition...
{ "abstract": "Blister formation and eccrine sweat gland necrosis have been recognized to occur in states of impaired consciousness and were first reported following barbiturate intoxication. Their etiology is complex and cannot simply be explained by pressure effects. Now that barbiturates are less frequently used, ...
[ { "companynumb": "GB-MYLANLABS-2020M1078187", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "2", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugadditional": "1", ...
{ "abstract": "Methemoglobinemia can result in severe hypoxia. It has been frequently reported during the use of inhaled nitric oxide, but can occur where nitrate containing medications are used. Glyceryl trinitrate (GTN) patches have been used in the treatment of digital and limb ischemia in prematurely born infants...
[ { "companynumb": "GB-ESPERO PHARMACEUTICALS-ESP201811-000045", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "NITROGLYCERIN" }, "drugaddit...
{ "abstract": "OBJECTIVE\nTo report a case of Corynebacterium striatum endocarditis that was treated successfully with daptomycin plus rifampin following an unsuccessful attempt at vancomycin desensitization and failure of linezolid therapy.\n\n\nMETHODS\nA 46-year-old woman with hemodialysis-dependent chronic renal ...
[ { "companynumb": "US-009507513-2204USA002703", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "DAPTOMYCIN" }, "drugadditional": "4", ...
{ "abstract": "Autoimmune hepatitis (AIH) is a disease of unknown aetiology with drug-induced AIH being the most complex and not fully understood type. We present the case of a 57-year-old female patient with acute icteric hepatitis after interferon-beta-1b (IFNβ-1b) administration for multiple sclerosis (MS). Based ...
[ { "companynumb": "GR-JUBILANT CADISTA PHARMACEUTICALS-2017JUB00003", "fulfillexpeditecriteria": "1", "occurcountry": "GR", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "METHYLPREDNISOLONE" }, ...
{ "abstract": "The use of non-steroidal anti-inflammatory drugs like diclofenac in the third trimester of pregnancy can cause severe side effects, in particular oligohydramnios, premature closure of ductus arteriosus, and fetal kidney damage. However, the treatment with non-steroidal anti-inflammatory drugs until ges...
[ { "companynumb": "DE-BAUSCH-BL-2017-021961", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugadditional": null, ...
{ "abstract": "A 68-year-old woman was receiving chemotherapy and endocrine therapy for right breast cancer postoperative pulmonary metastasis and local lymph node recurrence. However, she developed interstitial pneumonia 12 weeks after initiating treatment with everolimus and exemestane. Treatment with everolimus an...
[ { "companynumb": "JP-ALVOGEN-2021-ALVOGEN-116464", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "EXEMESTANE" }, "drugadditional": "1", ...
{ "abstract": "Anaesthesia induction and meticulous airway management is important in a patient with anterior mediastinal mass. It is all the more challenging if this is encountered in infants. We report a comrehensive successful management of an infant with huge anterior mediastinal mass who was anaesthesized for di...
[ { "companynumb": "IN-BAXTER-2019BAX015110", "fulfillexpeditecriteria": "1", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugadditional": null, ...
{ "abstract": "At the autopsy of a 25-year-old man who had died from combined morphine and cocaine intoxication, depositions of metallic mercury were incidentally found in the myocardium of the right ventricular septum and posterior wall. Deposits, toxicologically identified as mercury, were also found radiologically...
[ { "companynumb": "DE-PFIZER INC-2020386012", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "COCAINE" }, "drugadditional": null, ...
{ "abstract": "Dexmedetomidine, an α2-adrenergic agonist, can be used to perform mild to moderate sedation in critically ill patients. In this case series, 9 cardiovascular intensive care unit patients with hyperthermia during dexmedetomidine administration, suggestive of drug fever, are presented. Hyperthermia (>38....
[ { "companynumb": "CH-HQ SPECIALTY-CH-2017INT000298", "fulfillexpeditecriteria": "1", "occurcountry": "CH", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "DEXMEDETOMIDINE HYDROCHLORIDE" }, "dru...
{ "abstract": "Infective endocarditis in neonates can be fatal. Adjunctive rifampin therapy might be effective as salvage therapy in critically ill patients with Staphylococcus aureus native valve endocarditis (NVE). We present a case of a full-term neonate with NVE who had a favorable clinical outcome after adding r...
[ { "companynumb": "SA-LUPIN PHARMACEUTICALS INC.-2022-04018", "fulfillexpeditecriteria": "2", "occurcountry": "SA", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "RIFAMPIN" }, "drugadditional":...
{ "abstract": "BACKGROUND\nOsimertinib is a tyrosine kinase inhibitor that targets the epidermal growth factor receptor. Elevated serum creatine kinase level is an uncommon adverse event associated with osimertinib treatment for lung cancer.\n\n\nMETHODS\nWe report a previously healthy 56-year-old woman who developed...
[ { "companynumb": "2021A763042", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "OSIMERTINIB" }, "drugadditional": null, "drugadmi...
{ "abstract": "A 74-year-old woman with gross hematuria for 3 months was referred to our hospital. Contrast-enhanced computed tomographic scan showed a mass on the upper-right renal calyx, and retrograde pyelography showed stenoses from the renal pelvis to the renal calyx infundibulum. We performed an endoscopic biop...
[ { "companynumb": "JP-ELI_LILLY_AND_COMPANY-JP202108011251AA", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, ...
{ "abstract": "Acute liver failure has a high mortality and its most frequent cause in Spain is viral infection. In this article, we present a case of fulminant liver failure. The failure is secondary to an idiosyncratic reaction to ibuprofen, an entity included in the DRESS syndrome. This syndrome plays a key role i...
[ { "companynumb": "ES-RANBAXY-2014RR-91133", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugadditional": null, ...
{ "abstract": "Immunosuppressives have been used in multiple sclerosis (MS) since 1966. Today, we have many treatments for the relapsing forms of the disease, including 8 US Food and Drug Administration-approved therapies, with more soon to be introduced. Given the current treatment landscape what place do immunosupp...
[ { "companynumb": "US-TEVA-2021-US-1952605", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugadditional": "3...
{ "abstract": "To investigate the clinical efficacy of combination of mouse nerve growth factor (NGF) and nimodipine in the treatment of neonatal intracranial hemorrhage (NICH) and its effect on plasma platelet-activating factor (PAF), C-type natriuretic peptide (CNP), matrix metalloproteinase-2 (MMP-2), and neurolog...
[ { "companynumb": "CN-ARBOR PHARMACEUTICALS, LLC-CN-2021ARB000734", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "NIMODIPINE" }, "drugaddi...
{ "abstract": "Drug-induced aseptic meningitis (DIAM) represents a diagnostic challenge since clinical and cerebrospinal fluid (CSF) findings may be indistinguishable from a bacterial meningitis. Intravenous immunoglobulin (IVIg) are commonly used in a variety of diseases, including inflammatory and autoimmune disord...
[ { "companynumb": "IT-BEH-2019104170", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugadditional": "1", ...
{ "abstract": "Disease recurrence occurs in 20% to 40% of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are treated with chemotherapy and tyrosine kinase inhibitors (TKIs). In the current study, the authors report the incidence, treatment, and outcome after first disease recu...
[ { "companynumb": "PHHY2019ES096199", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DAUNORUBICIN" }, "drugadditional": "3", "dru...
{ "abstract": "Human immunodeficiency virus (HIV) causes a spectrum of immunodysfunction, the most severe of which is the acquired immunodeficiency syndrome (AIDS). We have followed the course of psoriasis in 13 patients over 2 1/2 years in a population of more than 1000 HIV-positive individuals. Four patients had a ...
[ { "companynumb": "US-PFIZER INC-2021719261", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "METHOTREXATE SODIUM" }, "drugadditional": "3",...
{ "abstract": "OBJECTIVE\nTo investigate the efficacy and safety of sildenafil added to inhaled nitric oxide (iNO) for newborn infants with persistent pulmonary hypertension of newborn (PPHN) or hypoxic respiratory failure (HRF) at risk of PPHN.\n\n\nMETHODS\nPart A of a multinational, randomized, double-blind, place...
[ { "companynumb": "GB-ALKEM LABORATORIES LIMITED-GB-ALKEM-2021-03377", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "3", "activesubstance": { "activesubstancename": "METHADONE HYDROCHLORIDE" }, ...
{ "abstract": "Dear Editor, Scleroderma associated with neoplasia is rare, with only a small number of cases reported. We describe 4 patients with paraneoplastic scleroderma who were treated at the I. Department of Dermatovenereology, St. Anna Hospital, during the period between 2004 and 2014. The patients were diagn...
[ { "companynumb": "CZ-SUN PHARMACEUTICAL INDUSTRIES LTD-2017R1-139465", "fulfillexpeditecriteria": "1", "occurcountry": "CZ", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "PREDNISONE" }, "drug...
{ "abstract": "Olanzapine is a second-generation antipsychotic. Incidence of olanzapine-induced seizures (OIS) is low with monotherapy. Combination therapy with another antipsychotic, drug metabolism and old age are risk factors for OIS. Our patient was a 71-year-old man, admitted to the psychiatry unit. He was manag...
[ { "companynumb": "GB-MACLEODS PHARMACEUTICALS US LTD-MAC2020024805", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "OLANZAPINE" }, "drugad...
{ "abstract": "To evaluate the efficacy and safety of pegylated interferon-lambda-1a (Lambda)/ribavirin (RBV)/daclatasvir (DCV) for treatment of patients coinfected with chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Treatment-naive patients were assigned to cohort A [HCV genotype (GT)-2 or -...
[ { "companynumb": "US-KADMON PHARMACEUTICALS, LLC-KAD201704-000615", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "RIBAVIRIN" }, "drugaddi...
{ "abstract": "We reported the case of a patient with stage IV Hodgkin's disease (involving the nodes and Liver) presenting with paraneoplastic fever and who subsequently developed hypothermia during chemotherapy administration. We also reviewed the 12 other cases of hypothermia in Hodgkin's disease reported in the l...
[ { "companynumb": "BE-PFIZER INC-2021678902", "fulfillexpeditecriteria": "1", "occurcountry": "BE", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "BLEOMYCIN SULFATE" }, "drugadditional": null,...
{ "abstract": "Paclitaxel and platinum combination is the standard chemotherapy regimen for patients with advanced epithelial ovarian cancer. The dose-limiting toxicity effects of this combination are myelosuppression and neuropathy. Herein, we report a case of a 71-year-old female with advanced epithelial ovarian ca...
[ { "companynumb": "TR-CIPLA LTD.-2014TR02873", "fulfillexpeditecriteria": "1", "occurcountry": "TR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nThis is the 26th Annual Report of the American Association of Poison Control Centers (AAPCC; http://www. aapcc.org ) National Poison Data System (NPDS). During 2008, 60 of the nation's 61 US poison centers uploaded case data automatically. The median upload time was 24 [7.2, 112] (median [2...
[ { "companynumb": "US-BAYER-201010798GPV", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\DIPHENHYDRAMINE" }, "drugaddition...
{ "abstract": "Transradial artery approach as primary access for transcatheter diagnosis and intervention is associated with lower risk of bleeding and major vascular complications, improved patient comfort and shorter time to hemostasis and ambulation than femoral one. Patient's adequate hand collateral perfusion, a...
[ { "companynumb": "IT-MYLANLABS-2019M1072394", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CLOPIDOGREL BISULFATE" }, "drugadditional": "...
{ "abstract": "In metastatic castration-resistant prostate cancer (mCRPC), assessing treatment response and bone lesions with technetium-99m is limited by image resolution and subjectivity. We evaluated bone scan lesion area (BSLA), a quantitative imaging assessment of response in patients with mCRPC receiving radium...
[ { "companynumb": "US-ASTELLAS-2021US011393", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "ENZALUTAMIDE" }, "drugadditional": null, ...
{ "abstract": "Immune checkpoint inhibitors (ICPis) induce various immune-related adverse events (irAEs), despite their beneficial effects in treating various advanced cancers. ICPi-induced secondary adrenal insufficiency is described as a prevalent and serious 'pituitary irAE.' However, its precise mechanism remains...
[ { "companynumb": "JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2019-116927", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "drugaddi...
{ "abstract": "Autologous peripheral blood stem cell transplantation(auto-PBSCT)combined with high-dose chemotherapy has been considered as the standard therapy for relapsed or induction therapy-refractory aggressive lymphomas sensitive to chemotherapy. While various regimens have been applied as the conditioning,non...
[ { "companynumb": "NVSC2019JP002692", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugadditional": null, "druga...
{ "abstract": "To evaluate the safety and efficacy of induced hypertension in patients with acute ischemic stroke.\n\n\n\nIn this multicenter randomized clinical trial, patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progre...
[ { "companynumb": "KR-MEITHEAL PHARMACEUTICALS-2019MHL00013", "fulfillexpeditecriteria": "1", "occurcountry": "KR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "PHENYLEPHRINE HYDROCHLORIDE" }, ...
{ "abstract": "Triamcinolone acetonide is a synthetic glucocorticoid used to treat numerous acute and chronic inflammatory conditions. The various side effects of this drug from parenteral administration are well documented in the literature. In this study, three patients present with a rare side effect of violaceous...
[ { "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-108670", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TRIAMCINOLONE ACETONIDE" }, ...
{ "abstract": "Lenalidomide (Len) and dexamethasone (dex) therapy is a standard therapy in patients with multiple myeloma. Elderly or unfit patients may reduce Len or dex doses to prevent toxicities that lead to treatment discontinuation. However, there have been few studies evaluating the efficacy and safety of lowe...
[ { "companynumb": "JP-CELGENEUS-JPN-20200902764", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugadditional": null, ...
{ "abstract": "A 40-year-old woman was admitted to the hospital for an acute outbreak of multiple pustular lesions with an underlying erythematous base affecting cheeks and chin. These lesions were referred to as \"aching\". The patient had been taking amoxicillin-clavulanic acid (3 g a day) over the past three days ...
[ { "companynumb": "IT-AUROBINDO-AUR-APL-2018-033043", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANIC ACID" }, "drug...
{ "abstract": "OBJECTIVE\nAdding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reporte...
[ { "companynumb": "ES-MYLANLABS-2017M1057843", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugadditional": null, ...
{ "abstract": "Disseminated intravascular coagulation is a complex and potentially lethal complication of malignancy, in which the fundamental abnormality is excessive activation of the coagulation system. It is a rare complication of melanoma which can be difficult to diagnose in some circumstances, leading to delay...
[ { "companynumb": "NVSC2020AU048953", "fulfillexpeditecriteria": "1", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DABRAFENIB" }, "drugadditional": "3", "druga...
{ "abstract": "Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome is a rare and life-threatening delayed drug hypersensitivity reaction characterized by skin eruption, fever, lymphadenopathies, and visceral involvement. Here, we are presenting a 12 year old boy, who developed rare but life threatening...
[ { "companynumb": "AR-ALKEM LABORATORIES LIMITED-AR-ALKEM-2018-07772", "fulfillexpeditecriteria": "1", "occurcountry": "AR", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LAMOTRIGINE" }, "drug...
{ "abstract": "FOLFIRINOX is a standard chemotherapeutic regimen for patients with advanced pancreatic cancer who have a good performance status. In this study, we present the case of a 64-year-old male who developed dysarthria following FOLFIRINOX treatment, and review all four cases of dysarthria encountered among ...
[ { "companynumb": "JP-FRESENIUS KABI-FK201504679", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugadditional": null,...
{ "abstract": "Pregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.\n\n\n\nBetween 2007 and 2019, pregnant women with IBD were...
[ { "companynumb": "US-JNJFOC-20170912250", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CERTOLIZUMAB PEGOL" }, "drugadditional": "3", ...
{ "abstract": "OBJECTIVE\nTo identify factors predicting primary resistance to new-generation hormonal agents (NHAs), abiraterone acetate and enzalutamide in patients with castration-resistant prostate cancer (CRPC).\n\n\nMETHODS\nOur hospital has conducted two successive named patient NHA programs. A total of 57 pat...
[ { "companynumb": "IT-ASTELLAS-2014EU011062", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": null, "activesubstance": null, "drugadditional": null, "drugadministrationroute": "065", "drugauth...
{ "abstract": "A multicentre phase II trial was conducted to evaluate the efficacy and toxicity of gemcitabine in patients with refractory or relapsed indolent non-Hodgkin's lymphoma. Thirty-six patients were enrolled onto the study, including 11 cases of mantle cell lymphoma (MCL), 10 cases of chronic lymphocytic le...
[ { "companynumb": "FR-PFIZER INC-2017468129", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugadditional"...
{ "abstract": "To investigate the effects of prior treatment and determine the predictors of a 12-month treatment response of romosozumab (ROMO) in 148 patients with postmenopausal osteoporosis.\n\n\n\nIn this prospective, observational, and multicenter study, treatment naïve patients (Naïve; n=50) or patients previo...
[ { "companynumb": "JP-AMGEN-JPNSP2021082139", "fulfillexpeditecriteria": "2", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugadditional": "4", ...
{ "abstract": "BACKGROUND\nDespite advances in the treatment of Hodgkin lymphoma with the introduction of PET-adapted regimens, practical challenges prevent more widespread use of these approaches. The ECHELON-1 study assessed the safety and efficacy of front-line A+AVD (brentuximab vedotin, doxorubicin, vinblastine,...
[ { "companynumb": "GB-PFIZER INC-2018492521", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "DOXORUBICIN HYDROCHLORIDE" }, "drugadditional"...
{ "abstract": "BACKGROUND\nPrimary focal segmental glomerular sclerosis (FSGS) recurs in 20 - 40% of patients after kidney transplantation. Rituximab has been used to treat several glomerular diseases.\n\n\nRESULTS\nWe treated two renal-transplant patients with recurrence of FSGS with rituximab. Despite a prophylacti...
[ { "companynumb": "FR-BAUSCH-BL-2019-018786", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "PREDNISOLONE" }, "drugadditional": "3", ...
{ "abstract": "Atrial masses are an uncommon but serious clinical problem. The authors report a case of an atrial mass associated with a tunnelled vascular access catheter in an immunosuppressed haemodialysis patient. In the setting of immunosuppression with fevers, a broad differential for the atrial mass was consid...
[ { "companynumb": "AU-ASTELLAS-2020US024024", "fulfillexpeditecriteria": "1", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugadditional": null, ...
{ "abstract": "While the developed nations are discussing giving a third dose of the COVID-19 vaccine to immunocompromised individuals, there are still challenges that are of global concern, especially in developing countries. The Delta variant which is predominantly responsible for the disease burden has now been re...
[ { "companynumb": "IN-LUPIN LIMITED-2022-06230", "fulfillexpeditecriteria": "2", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "RIFAMPIN" }, "drugadditional": "4", ...
{ "abstract": "OBJECTIVE\nA case is presented to illustrate a potential effect of Chinese herbal medicine (CHM) formulas in treating chemotherapy-induced cardiotoxicity.\n\n\nMETHODS\nAn 18-year-old adolescent male with refractory acute lymphoblastic leukemia (ALL) had experienced anthracycline-induced congestive hea...
[ { "companynumb": "TW-SA-2015SA026443", "fulfillexpeditecriteria": "1", "occurcountry": "TW", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugadditional": null, "d...
{ "abstract": "An 84-year-old African American woman was admitted to the hospital secondary to severe abdominal pain accompanied by septic shock. She underwent exploratory laparotomy, which revealed extensive small bowel necrosis likely due to small bowel torsion. A small bowel resection was performed with primary an...
[ { "companynumb": "US-BAUSCH-BL-2018-002309", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "BIMATOPROST" }, "drugadditional": null, ...
{ "abstract": "Giant cell tumour of bone (GCTOB) is a relatively uncommon, benign, but locally aggressive neoplasm. Denosumab is a fully human monoclonal antibody with inhibitory effects on receptor activator of nuclear factor kappa-B ligand that has shown early promise as a possible treatment adjuvant for GCTB. Howe...
[ { "companynumb": "AU-AMGEN-AUSSP2020129470", "fulfillexpeditecriteria": "2", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugadditional": "3", ...
{ "abstract": "Pediatric primary lung carcinomas are extremely rare. Apart from known associations with congenital adenomatoid malformations, cases of primary lung adenocarcinomas after prolonged treatments of pediatric malignancy have been reported. We describe the morphological and molecular features of three cases...
[ { "companynumb": "IT-TEVA-2021-IT-1944475", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nHemolytic-uremic syndrome (HUS) presents with hemolytic anemia, thrombocytopenia, and thrombotic microangiopathy of the kidney and usually results from Shiga-toxin induced activation of the alternative complement pathway. Gastroenteritis is a common feature of the Shiga-toxin producing Esch...
[ { "companynumb": "BR-ALEXION-A201803569", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ECULIZUMAB" }, "drugadditional": "3", "...
{ "abstract": "OBJECTIVE\nTo determine the incidence of major complications in patients undergoing regional anesthesia (RA) in China.\n\n\nMETHODS\nMulticenter prospective survey.\n\n\nMETHODS\nEleven teaching hospitals in China.\n\n\nMETHODS\nA total of 106,569 patients undergoing RA from April 1, 2009, to April 30,...
[ { "companynumb": "CN-FRESENIUS KABI-FK201704407", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ROPIVACAINE" }, "drugadditional": null, ...
{ "abstract": "To help curb the opioid overdose epidemic, many states are implementing overdose education and naloxone distribution (OEND) programs. Few evaluations of these programs exist. Maryland's OEND program incorporated the services of the poison center. It asked bystanders to call the poison center within 2 h...
[ { "companynumb": "US-PFIZER INC-2016289141", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "METHADONE HYDROCHLORIDE" }, "drugadditional":...
{ "abstract": "Pseudotumor cerebri is a syndrome characterized by an elevated intracranial pressure greater than 20 cmH2O with ventricles and cerebrospinal fluid of normal characteristics. Consumption of minocycline have been described among the causes associated with this syndrome. We present a 13-year old female pa...
[ { "companynumb": "AR-IMPAX LABORATORIES, INC-2016-IPXL-00457", "fulfillexpeditecriteria": "1", "occurcountry": "AR", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "MINOCYCLINE HYDROCHLORIDE" }, ...
{ "abstract": "BACKGROUND\nIdiopathic membranous nephropathy (IMN) is the most common cause of nephrotic syndrome in adults. Although various studies have demonstrated the efficacy of tacrolimus combined with corticosteroids for treating IMN, both tacrolimus and corticosteroids have been shown to be diabetogenic, par...
[ { "companynumb": "CN-ACCORD-159900", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": "3", "druga...
{ "abstract": "We present our experience in the hematopoietic stem cell transplantation (HSCT) in two children diagnosed with Mendelian susceptibility to mycobacterial diseases. The first child underwent a haploidentical HSCT with posttransplant cyclophosphamide using a reduced intensity conditioning following which ...
[ { "companynumb": "IN-ADIENNEP-2020AD000221", "fulfillexpeditecriteria": "1", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nChoriocarcinoma is a subtype of gestational trophoblastic disease, gestational trophoblastic neoplasia. Patients with brain metastasis are rare and information on the optimal treatment and patient outcome is limited. In order to improve the prognosis of this disease, accurate and timely tre...
[ { "companynumb": "CN-Accord-245848", "fulfillexpeditecriteria": "1", "occurcountry": "CN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugadditional": "3", "drugad...
{ "abstract": "There are few case reports of concomitant chronic inflammatory demyelinating polyneuropathy (CIDP) and focal segmental glomerulosclerosis. A rare autoantibody to a neuronal and podocyte structural component, neurofascin, may be contributory. A Black man in his 40s presented with worsening polyneuropath...
[ { "companynumb": "US-STRIDES ARCOLAB LIMITED-2021SP005238", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional...
{ "abstract": "Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical manifestations are diverse and can vary from mild respiratory symptoms to severe hypoxic respiratory failure. In severe cases, infection can cause gastrointestinal, renal, cardiac, ne...
[ { "companynumb": "US-FRESENIUS KABI-FK202112048", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "VANCOMYCIN" }, "drugadditional": "1", ...
{ "abstract": "Antibiotic prophylaxis is a routine procedure in management of burns. As such it is a safe practice, yet unusual complications can occur with the use of even safest antibiotics and their emergency management may be life saving. Here we present a case of 35% second and third degree burns who was taken f...
[ { "companynumb": "IN-VALIDUS PHARMACEUTICALS LLC-IN-2021VAL000971", "fulfillexpeditecriteria": "1", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugaddit...
{ "abstract": "OBJECTIVE\nTo clarify whether anti-epileptic drug exposure during pregnancy is associated with an increased risk of intrauterine foetal death.\n\n\nMETHODS\nAnalysis of data from 2064 pregnancies with known outcomes included in the Australian Register of Antiepileptic Drugs in Pregnancy, 170 of the pre...
[ { "companynumb": "AU-UNICHEM PHARMACEUTICALS (USA) INC-UCM201806-000146", "fulfillexpeditecriteria": "1", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "TOPIRAMATE" }, "d...