src stringlengths 51 3.39k | tgt stringlengths 51 3.39k | bleu float64 0 1 | tgt_index listlengths 1 495 | original_filename stringlengths 7 201 | filename stringlengths 8 13 | page_idx int64 0 1.6k | src_layout listlengths 1 495 | tgt_layout listlengths 1 495 |
|---|---|---|---|---|---|---|---|---|
and audio-visual material Training will be delivered in one and it is expected that similar of two ways: materials will be 1. Internet-based implemented for the Peyronie’s indication. 2. Peer-to-peer meetings Training will be linked to a Prescriber Certification Program described in Clinical Study Report Question 11. C... | and audio-visual material and it is expected that similar materials will be implemented for the Peyronie’s indication. Training will be delivered in one of two ways: 1. Internet-based 2. Peer-to-peer meetings Training will be linked to a Prescriber Certification Program described in Clinical Study Report Question 11. C... | 0.750065 | [
0,
1,
2,
9,
10,
11,
12,
13,
14,
18,
19,
20,
23,
24,
25,
26,
27,
3,
4,
5,
6,
7,
8,
15,
16,
17,
21,
22,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-collagenase-clostridium-histolyticum-160802.docx | task-634-197 | 32 | [
[
157,
91,
184,
107
],
[
187,
91,
275,
107
],
[
279,
91,
340,
107
],
[
416,
91,
477,
107
],
[
481,
91,
506,
107
],
[
510,
91,
526,
107
],
[
530,
91,
594,
107
],
[
598,
... | [
[
157,
91,
184,
107
],
[
187,
91,
275,
107
],
[
279,
91,
340,
107
],
[
157,
105,
184,
121
],
[
187,
105,
198,
121
],
[
201,
105,
213,
121
],
[
217,
105,
281,
121
],
[
285,
... |
where it appears the EU SmPC is more restrictive. A table summarising the The sponsor states: This is “Tables pharmacovigilance and summarising planned generally risk minimisation activities pharmacovigilance actions acceptable, for all of the specified (see section 1.13.1 although ongoing safety concerns Australian Sp... | where it appears the EU SmPC is more restrictive. A table summarising the pharmacovigilance and risk minimisation activities for all of the specified ongoing safety concerns and missing information proposed for Australia should be included in the revised ASA. The sponsor states: “Tables summarising planned pharmacovigi... | 0.604139 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
19,
20,
24,
25,
26,
30,
31,
32,
33,
34,
39,
40,
41,
47,
48,
49,
55,
56,
57,
64,
65,
66,
67,
68,
74,
75,
13,
14,
15,
18,
21,
22,
27,
28,
35,
36,
37,
42,
43,
44,
50,
51... | auspar-albumin-human-170502.docx | task-634-21 | 25 | [
[
174,
90,
225,
108
],
[
229,
90,
240,
108
],
[
244,
90,
307,
108
],
[
311,
90,
337,
108
],
[
341,
90,
363,
108
],
[
174,
106,
220,
124
],
[
224,
106,
237,
124
],
[
241,
... | [
[
174,
90,
225,
108
],
[
229,
90,
240,
108
],
[
244,
90,
307,
108
],
[
311,
90,
337,
108
],
[
341,
90,
363,
108
],
[
174,
106,
220,
124
],
[
224,
106,
237,
124
],
[
241,
... |
Xgeva zoledronic Xgeva zoledronic Xgeva zoledronic zoledronic acid acid acid acid N 1026 1020 886 890 950 951 2862 2861 First SRE Median NR 26.4 20.6 16.3 20.7 17.1 27.6 19.4 time (months) Diff in NA 4.2 3.5 8.2 median time (months) Hazard trial 0.82 (0.71, 0.95) 0.84 (0.71, 0.98) 0.82 (0.71, 0.95) 0.83 (0.76, 0.90) (9... | Xgeva zoledronic acid Xgeva zoledronic acid Xgeva zoledronic acid zoledronic acid N 1026 1020 886 890 950 951 2862 2861 First SRE Median time (months) NR 26.4 20.6 16.3 20.7 17.1 27.6 19.4 Diff in median time (months) NA 4.2 3.5 8.2 Hazard (95% CI) 0.82 (0.71, 0.95) 0.84 (0.71, 0.98) 0.82 (0.71, 0.95) 0.83 (0.76, 0.90)... | 0.631083 | [
0,
1,
7,
2,
3,
8,
4,
5,
9,
6,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
31,
32,
23,
24,
25,
26,
27,
28,
29,
30,
33,
34,
39,
40,
41,
35,
36,
37,
38,
42,
56,
57,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53... | auspar-denosumab-140417-pi.docx | task-634-227 | 3 | [
[
240,
217,
291,
236
],
[
313,
217,
395,
236
],
[
416,
217,
467,
236
],
[
488,
217,
570,
236
],
[
591,
217,
642,
236
],
[
664,
217,
746,
236
],
[
828,
217,
909,
236
],
[
31... | [
[
240,
217,
291,
236
],
[
313,
217,
395,
236
],
[
313,
233,
346,
252
],
[
416,
217,
467,
236
],
[
488,
217,
570,
236
],
[
488,
233,
521,
252
],
[
591,
217,
642,
236
],
[
66... |
As with any elective injection procedure, As ‘Infections’ should be treatment with Belkyra is contraindicated added as an for patients with infection in the treatment Important area. Further, no post-treatment infections Potential Risk. were observed during the clinical trials in Belkyra or placebo patients. Given that... | ‘Infections’ should be added as an Important Potential Risk. As with any elective injection procedure, treatment with Belkyra is contraindicated for patients with infection in the treatment area. Further, no post-treatment infections were observed during the clinical trials in Belkyra or placebo patients. Given that st... | 0.666976 | [
7,
8,
9,
15,
16,
17,
25,
31,
32,
0,
1,
2,
3,
4,
5,
10,
11,
12,
13,
14,
18,
19,
20,
21,
22,
23,
24,
26,
27,
28,
29,
30,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54,
5... | auspar-deoxycholic-acid-170406.docx | task-634-231 | 31 | [
[
332,
97,
352,
115
],
[
356,
97,
392,
115
],
[
396,
97,
424,
115
],
[
429,
97,
489,
115
],
[
493,
97,
562,
115
],
[
566,
97,
652,
115
],
[
726,
97,
745,
115
],
[
157,
... | [
[
157,
99,
243,
114
],
[
157,
113,
210,
131
],
[
214,
113,
233,
131
],
[
157,
128,
205,
146
],
[
209,
128,
226,
146
],
[
230,
128,
250,
146
],
[
157,
143,
238,
161
],
[
157... |
the ongoing table of safety table of ongoing safety hepatic and renal concerns, and concerns as missing impairment and pharmacovigilance and risk information in the table of C.) previously minimisation activities should ongoing safety concerns untreated patients. be assigned as appropriate. based on the clinical Risk-M... | the ongoing table of safety concerns, and pharmacovigilance and risk minimisation activities should be assigned as appropriate. C.) It is recommended that “previously untreated patients” be included in the table of ongoing safety as missing information. Pharmacovigilance and risk minimisation activities should be assig... | 0.647086 | [
0,
1,
2,
3,
4,
12,
13,
19,
20,
21,
29,
30,
31,
37,
38,
39,
40,
50,
51,
52,
53,
54,
63,
56,
57,
67,
68,
69,
70,
71,
72,
77,
78,
79,
80,
85,
86,
87,
88,
89,
90,
91,
92,
93,
94,
95,
96,
97,
98,
99,
100,
105,
101,
... | auspar-efmoroctocog-alfa-rhu-150317.docx | task-634-263 | 28 | [
[
142,
90,
168,
108
],
[
172,
90,
235,
108
],
[
240,
90,
279,
108
],
[
283,
90,
298,
108
],
[
302,
90,
349,
108
],
[
419,
90,
458,
108
],
[
463,
90,
478,
108
],
[
482,
... | [
[
142,
90,
168,
108
],
[
172,
90,
235,
108
],
[
240,
90,
279,
108
],
[
283,
90,
298,
108
],
[
302,
90,
349,
108
],
[
142,
106,
217,
124
],
[
221,
106,
251,
124
],
[
142,
... |
Black race population Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 6. Table 6: Additional pharmacovigil... | Black race population Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 6. Table 6: Additional pharmacovigil... | 0.589026 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
51,
52,
50,
53,
54... | auspar-eltrombopag-160330.docx | task-634-277 | 19 | [
[
366,
90,
411,
107
],
[
415,
90,
450,
107
],
[
454,
90,
543,
107
],
[
142,
133,
305,
151
],
[
309,
133,
347,
151
],
[
142,
156,
172,
174
],
[
177,
156,
240,
174
],
[
244,
... | [
[
366,
90,
411,
107
],
[
415,
90,
450,
107
],
[
454,
90,
543,
107
],
[
142,
133,
305,
151
],
[
309,
133,
347,
151
],
[
142,
156,
172,
174
],
[
177,
156,
240,
174
],
[
244,
... |
Submission details Identifying information Submission number PM-2016-02313-1-1 Sponsor Allergan Australia Trade name Viberzi Active substance Eluxadoline Submission type This was an application to register eluxadoline as a new chemical entity under the proposed trade name Viberzi. Drug class and therapeutic indication ... | Submission details Identifying information Submission number PM-2016-02313-1-1 Sponsor Allergan Australia Trade name Viberzi Active substance Eluxadoline Submission type This was an application to register eluxadoline as a new chemical entity under the proposed trade name Viberzi. Drug class and therapeutic indication ... | 0.963395 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
52,
49,
50,
51,
53,
54... | auspar-eluxadoline-180516-cer.docx.docx | task-634-279 | 5 | [
[
168,
117,
320,
143
],
[
328,
117,
413,
143
],
[
197,
163,
307,
184
],
[
313,
163,
433,
184
],
[
120,
196,
219,
214
],
[
223,
196,
290,
214
],
[
344,
196,
506,
214
],
[
12... | [
[
168,
117,
320,
143
],
[
328,
117,
413,
143
],
[
197,
163,
307,
184
],
[
313,
163,
433,
184
],
[
120,
196,
219,
214
],
[
223,
196,
290,
214
],
[
344,
196,
506,
214
],
[
12... |
relation to Dose) study drug) Female, 24 None / None 2 Cycles (96 Thyroid 688 days 315 days mg) cancer (23 months) (10 (Grade 3, months) serious, related) Female, 46 Dysplastic naevus 2 Cycles (90 Basal cell (~19 (~5 syndrome, mg) carcinoma months) months) thyroid neoplasm, (Grade 3, thyroidectomy / serious, former tob... | Dose) relation to study drug) Female, 24 None / None 2 Cycles (96 mg) Thyroid cancer (Grade 3, serious, related) 688 days (23 months) 315 days (10 months) Female, 46 Dysplastic naevus syndrome, thyroid neoplasm, thyroidectomy / former tobacco use 2 Cycles (90 mg) Basal cell carcinoma (Grade 3, serious, related) (~19 mo... | 0.366297 | [
2,
0,
1,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
18,
13,
19,
23,
24,
26,
27,
14,
15,
20,
21,
16,
17,
22,
25,
28,
29,
30,
31,
39,
44,
45,
48,
49,
51,
52,
54,
32,
33,
34,
40,
35,
36,
41,
46,
47,
50,
53,
37,
42,
38,
43... | auspar-alemtuzumab-140204.docx | task-634-28 | 39 | [
[
524,
192,
586,
208
],
[
590,
192,
605,
208
],
[
419,
206,
464,
222
],
[
524,
206,
567,
222
],
[
570,
206,
614,
222
],
[
142,
236,
198,
252
],
[
202,
236,
220,
252
],
[
25... | [
[
419,
206,
464,
222
],
[
524,
192,
586,
208
],
[
590,
192,
605,
208
],
[
524,
206,
567,
222
],
[
570,
206,
614,
222
],
[
142,
236,
198,
252
],
[
202,
236,
220,
252
],
[
25... |
Irritable bowel syndrome, constipation predominant IBS-c Irritable bowel syndrome, diarrhoea predominant IBS-d IBS-m Irritable bowel syndrome, mixed diarrhoea and constipation symptoms IBS-u Irritable bowel syndrome, unspecified ICH International Conference on Harmonisation IP Intraperitoneal Intravenous/intravenously ... | IBS-c Irritable bowel syndrome, constipation predominant IBS-d Irritable bowel syndrome, diarrhoea predominant IBS-m Irritable bowel syndrome, mixed diarrhoea and constipation symptoms IBS-u Irritable bowel syndrome, unspecified ICH International Conference on Harmonisation IP Intraperitoneal IV Intravenous/intravenous... | 0.672181 | [
5,
0,
1,
2,
3,
4,
11,
6,
7,
8,
9,
10,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
34,
33,
38,
35,
36,
37,
39,
40,
41,
42,
43,
44,
45,
49,
46,
47,
48,
53,
50,
51,
52,
54... | auspar-eluxadoline-180516.docx.docx | task-634-280 | 5 | [
[
309,
97,
374,
115
],
[
378,
97,
427,
115
],
[
431,
97,
514,
115
],
[
518,
97,
616,
115
],
[
620,
97,
724,
115
],
[
157,
98,
194,
114
],
[
309,
128,
374,
146
],
[
378,
... | [
[
157,
98,
194,
114
],
[
309,
97,
374,
115
],
[
378,
97,
427,
115
],
[
431,
97,
514,
115
],
[
518,
97,
616,
115
],
[
620,
97,
724,
115
],
[
157,
129,
196,
145
],
[
309,
... |
Copyright © Commonwealth of Australia 2013 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any comm... | Copyright © Commonwealth of Australia 2013 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any comm... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-elvitegravir-131216-cer.docx | task-634-281 | 2 | [
[
142,
90,
207,
103
],
[
142,
101,
155,
115
],
[
158,
101,
254,
115
],
[
257,
101,
269,
115
],
[
272,
101,
328,
115
],
[
331,
101,
362,
115
],
[
142,
113,
169,
127
],
[
172... | [
[
142,
90,
207,
103
],
[
142,
101,
155,
115
],
[
158,
101,
254,
115
],
[
257,
101,
269,
115
],
[
272,
101,
328,
115
],
[
331,
101,
362,
115
],
[
142,
113,
169,
127
],
[
172... |
About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designe... | October 2017 Australian Public Assessment Report for Empagliflozin Proprietary Product Name: Jardiance Sponsor: Boehringer Ingelheim Pty Ltd About the Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regula... | 0.969547 | [
167,
168,
63,
64,
65,
66,
67,
68,
69,
70,
71,
72,
73,
74,
75,
76,
77,
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
... | auspar-empagliflozin-171026.docx | task-634-290 | 0 | [
[
142,
132,
220,
159
],
[
227,
132,
268,
159
],
[
275,
132,
427,
159
],
[
435,
132,
520,
159
],
[
527,
132,
717,
159
],
[
724,
132,
799,
159
],
[
172,
162,
202,
180
],
[
20... | [
[
142,
673,
258,
702
],
[
267,
673,
334,
702
],
[
142,
276,
340,
318
],
[
353,
276,
474,
318
],
[
487,
276,
728,
318
],
[
741,
276,
874,
318
],
[
142,
311,
194,
354
],
[
20... |
Toxicity FTC (Emtriva) A comprehensive package of toxicology studies was submitted in support of FTC registration, documenting toxicity in rodents, chronic toxicity in rodents and monkeys (up to 312 months), carcinogenicity studies in rodents (up to 2 years), genotoxicity in vitro and in vivo, reproductive toxicity in ... | Toxicity FTC (Emtriva) A comprehensive package of toxicology studies was submitted in support of FTC registration, documenting toxicity in rodents, chronic toxicity in rodents and monkeys (up to 312 months), carcinogenicity studies in rodents (up to 2 years), genotoxicity in vitro and in vivo, reproductive toxicity in ... | 0.785045 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-emtricitabine-161220.docx | task-634-296 | 22 | [
[
142,
89,
225,
110
],
[
142,
128,
175,
146
],
[
179,
128,
262,
146
],
[
142,
151,
154,
169
],
[
158,
151,
279,
169
],
[
283,
151,
347,
169
],
[
351,
151,
367,
169
],
[
371... | [
[
142,
89,
225,
110
],
[
142,
128,
175,
146
],
[
179,
128,
262,
146
],
[
142,
151,
154,
169
],
[
158,
151,
279,
169
],
[
283,
151,
347,
169
],
[
351,
151,
367,
169
],
[
371... |
by blood pressure 10 to 25 mg which may be response repeated every 5 to 10 minute until the desired response is obtained. During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient’s normal blood pressure. In previously normotensive patients, systolic blood pressure should ... | by blood pressure response 10 to 25 mg which may be repeated every 5 to 10 minute until the desired response is obtained. During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient’s normal blood pressure. In previously normotensive patients, systolic blood pressure should ... | 0.766303 | [
0,
1,
2,
10,
3,
4,
5,
6,
7,
8,
9,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-ephedrine-hydrochloride-171013-cer.docx | task-634-306 | 12 | [
[
253,
177,
271,
194
],
[
275,
177,
316,
194
],
[
319,
177,
382,
194
],
[
669,
177,
688,
194
],
[
691,
177,
706,
194
],
[
710,
177,
728,
194
],
[
732,
177,
754,
194
],
[
75... | [
[
253,
177,
271,
194
],
[
275,
177,
316,
194
],
[
319,
177,
382,
194
],
[
253,
192,
319,
208
],
[
669,
177,
688,
194
],
[
691,
177,
706,
194
],
[
710,
177,
728,
194
],
[
73... |
Table 3 Adverse reactions reported with Praluent in pooled controlled studies System Common Rare Organ Class Immune hypersensitivity system hypersensitivity disorders vasculitis Respiratory, Upper thoracic and respiratory mediastinal tract signs disorders and symptoms* Skin and Pruritus urticaria subcutaneous eczema ti... | Table 3 Adverse reactions reported with Praluent in pooled controlled studies System Organ Class Common Rare Immune system disorders hypersensitivity hypersensitivity vasculitis Respiratory, thoracic and mediastinal disorders Upper respiratory tract signs and symptoms* Skin and subcutaneous tissue disorders Pruritus ur... | 0.659458 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
14,
15,
12,
13,
16,
18,
20,
17,
19,
21,
22,
24,
25,
27,
30,
23,
26,
28,
29,
31,
32,
33,
34,
37,
39,
41,
35,
36,
38,
40,
42,
44,
45,
47,
49,
50,
43,
46,
48,
51,
52,
53,
54... | auspar-alirocumab-rch-161213-pi.docx | task-634-32 | 18 | [
[
221,
210,
265,
227
],
[
269,
210,
279,
227
],
[
288,
210,
354,
227
],
[
359,
210,
434,
227
],
[
438,
210,
506,
227
],
[
511,
210,
545,
227
],
[
549,
210,
616,
227
],
[
62... | [
[
221,
210,
265,
227
],
[
269,
210,
279,
227
],
[
288,
210,
354,
227
],
[
359,
210,
434,
227
],
[
438,
210,
506,
227
],
[
511,
210,
545,
227
],
[
549,
210,
616,
227
],
[
62... |
The proposed indication for this drug is to slow DR progression. The disease process involved is the effect of diabetes in causing a complication of DR, which becomes progressively worse. The claim is not to cure DR, but to slow the rate of progression, which is measured by changes in Early Treatment Diabetic Retinopat... | The proposed indication for this drug is to slow DR progression. The disease process involved is the effect of diabetes in causing a complication of DR, which becomes progressively worse. The claim is not to cure DR, but to slow the rate of progression, which is measured by changes in Early Treatment Diabetic Retinopat... | 0.789331 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-fenofibrate-141208.docx | task-634-361 | 8 | [
[
142,
106,
172,
124
],
[
177,
106,
251,
124
],
[
256,
106,
335,
124
],
[
339,
106,
362,
124
],
[
366,
106,
396,
124
],
[
400,
106,
437,
124
],
[
441,
106,
454,
124
],
[
45... | [
[
142,
106,
172,
124
],
[
177,
106,
251,
124
],
[
256,
106,
335,
124
],
[
339,
106,
362,
124
],
[
366,
106,
396,
124
],
[
400,
106,
437,
124
],
[
441,
106,
454,
124
],
[
45... |
Beta-adrenergic receptor antagonists (β-blockers) and eformoterol fumarate may inhibit the effect of each other when administered concurrently. may also produce severe β-blockers bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with However, under certain circumstances,... | Beta-adrenergic receptor antagonists (β-blockers) and eformoterol fumarate may inhibit the effect of each other when administered concurrently. β-blockers may also produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with β-blockers. However, under certain ci... | 0.790942 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
21,
17,
18,
19,
20,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
44,
36,
37,
38,
39,
40,
41,
42,
43,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-fluticasone-proprionate-130613-pi.docx | task-634-390 | 13 | [
[
147,
111,
272,
132
],
[
282,
111,
346,
132
],
[
356,
111,
444,
132
],
[
455,
111,
551,
132
],
[
561,
111,
589,
132
],
[
599,
111,
692,
132
],
[
702,
111,
772,
132
],
[
78... | [
[
147,
111,
272,
132
],
[
282,
111,
346,
132
],
[
356,
111,
444,
132
],
[
455,
111,
551,
132
],
[
561,
111,
589,
132
],
[
599,
111,
692,
132
],
[
702,
111,
772,
132
],
[
78... |
Evaluator’s commentary on the clinical dossier The dossier was comprehensive. Pharmacokinetics Studies providing pharmacokinetic information The following PK studies were submitted (Table 2): Table 2: Submitted pharmacokinetic studies PK Subtopic * Synopsis topic ID PK in General * To assess healthy PK - the safety adu... | Evaluator’s commentary on the clinical dossier The dossier was comprehensive. Pharmacokinetics Studies providing pharmacokinetic information The following PK studies were submitted (Table 2): Table 2: Submitted pharmacokinetic studies PK topic Subtopic ID * Synopsis PK in healthy adults General PK - Single dose * To as... | 0.795679 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
32,
29,
33,
30,
31,
34,
35,
40,
45,
36,
41,
42,
46,
48,
37,
38,
39,
43,
44,
47,
49,
50,
51,
52,
53,
54... | auspar-follitropin-delta-rhu-171025-cer.docx | task-634-394 | 11 | [
[
197,
89,
314,
110
],
[
320,
89,
450,
110
],
[
456,
89,
483,
110
],
[
489,
89,
522,
110
],
[
528,
89,
602,
110
],
[
608,
89,
685,
110
],
[
120,
114,
151,
132
],
[
155,
... | [
[
197,
89,
314,
110
],
[
320,
89,
450,
110
],
[
456,
89,
483,
110
],
[
489,
89,
522,
110
],
[
528,
89,
602,
110
],
[
608,
89,
685,
110
],
[
120,
114,
151,
132
],
[
155,
... |
PK in healthy General PK Single dose C0524T15 Absolute adults bioavailability of golimumab 100 mg SC in healthy Multi dose NND subjects Bioequivalence† Single dose NND NDD Food effect NA PK in special Target population § populations Single dose NND Multi-dose C0524T14 PK/PD of golimumab SC 100 mg 4 weeks and IV 2 mg/kg... | PK in healthy adults General PK Single dose Multi dose C0524T15 NND Absolute bioavailability of golimumab 100 mg SC in healthy subjects Bioequivalence† Single dose NND NDD Food effect NA PK in special populations Target population § Single dose Multi-dose NND C0524T14 PK/PD of golimumab SC 100 mg 4 weeks and IV 2 mg/kg... | 0.82616 | [
0,
1,
2,
9,
3,
4,
5,
6,
18,
19,
7,
20,
8,
10,
11,
12,
13,
14,
15,
16,
17,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
36,
33,
34,
35,
37,
38,
40,
39,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-golimumab-130816.docx | task-634-406 | 8 | [
[
142,
116,
162,
132
],
[
166,
116,
180,
132
],
[
184,
116,
237,
132
],
[
271,
116,
326,
132
],
[
330,
116,
350,
132
],
[
392,
116,
436,
132
],
[
439,
116,
473,
132
],
[
50... | [
[
142,
116,
162,
132
],
[
166,
116,
180,
132
],
[
184,
116,
237,
132
],
[
142,
130,
187,
147
],
[
271,
116,
326,
132
],
[
330,
116,
350,
132
],
[
392,
116,
436,
132
],
[
43... |
Common abbreviations Abbreviation Meaning ADHD Attention Deficit Hyperactivity Disorder ADHD-RS-IV Attention Deficit Hyperactivity Disorder Rating Scale, Version IV – AE Adverse Event ALT Alanine aminotransferase ANCOVA Analysis of covariance ANOVA Analysis of variance AST Aspartate aminotransferase BP Blood pressure b... | Common abbreviations Abbreviation Meaning ADHD Attention Deficit Hyperactivity Disorder ADHD-RS-IV Attention Deficit Hyperactivity Disorder – Rating Scale, Version IV AE Adverse Event ALT Alanine aminotransferase ANCOVA Analysis of covariance ANOVA Analysis of variance AST Aspartate aminotransferase BP Blood pressure b... | 0.810151 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
18,
14,
15,
16,
17,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-guanfacine-180503.docx | task-634-418 | 4 | [
[
142,
111,
259,
137
],
[
266,
111,
441,
137
],
[
157,
149,
269,
167
],
[
315,
149,
388,
167
],
[
157,
180,
205,
198
],
[
315,
180,
390,
198
],
[
394,
180,
446,
198
],
[
45... | [
[
142,
111,
259,
137
],
[
266,
111,
441,
137
],
[
157,
149,
269,
167
],
[
315,
149,
388,
167
],
[
157,
180,
205,
198
],
[
315,
180,
390,
198
],
[
394,
180,
446,
198
],
[
45... |
Biopharmaceutics Several biopharmacetic studies were provided in support of this submission. The following studies were evaluated (see 2): 2: Biopharmaceutic studies submitted number Study type Study SPD503-104 Food effect (single 4 Full Food increased mg) Cmax and AUC by (food effect & relative 75% and 38%, bioavailab... | Biopharmaceutics Several biopharmacetic studies were provided in support of this submission. The following studies were evaluated (see 2): 2: Biopharmaceutic studies submitted number Study type Study SPD503-104 (food effect & relative bioavailability) Food effect (single 4 mg) Relative bioavailability (1 x4 mg vs 4 x 1... | 0.696145 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
39,
40,
41,
42,
46,
27,
28,
29,
30,
34,
47,
49,
50,
51,
52,
53,
54,
55,
56,
57,
31,
32,
33,
35,
36,
37,
38,
43... | auspar-guanfacine-180503.docx | task-634-418 | 12 | [
[
142,
89,
332,
110
],
[
142,
114,
200,
132
],
[
212,
114,
335,
132
],
[
347,
114,
404,
132
],
[
415,
114,
455,
132
],
[
467,
114,
539,
132
],
[
551,
114,
566,
132
],
[
578... | [
[
142,
89,
332,
110
],
[
142,
114,
200,
132
],
[
212,
114,
335,
132
],
[
347,
114,
404,
132
],
[
415,
114,
455,
132
],
[
467,
114,
539,
132
],
[
551,
114,
566,
132
],
[
578... |
Common abbreviations Abbreviation Meaning ACR20 American College of Rheumatology response 20% improvement ≥ American College of Rheumatology response 50% improvement ≥ ACR70 American College of Rheumatology response 70% improvement ≥ ACSOM Advisory Committee on the Safety of Medicines ADA Anti-drug antibody ADCC Antibo... | Common abbreviations Abbreviation Meaning ACR20 American College of Rheumatology response ≥ 20% improvement American College of Rheumatology response ≥ 50% improvement ACR70 American College of Rheumatology response ≥ 70% improvement ACSOM Advisory Committee on the Safety of Medicines ADA Anti-drug antibody ADCC Antibo... | 0.893241 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
12,
10,
11,
13,
14,
15,
16,
17,
20,
18,
19,
21,
22,
23,
24,
25,
26,
29,
27,
28,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-infliximab-171012.docx | task-634-460 | 4 | [
[
142,
303,
259,
329
],
[
266,
303,
441,
329
],
[
142,
341,
254,
359
],
[
294,
341,
367,
359
],
[
157,
372,
210,
390
],
[
309,
372,
385,
390
],
[
389,
372,
446,
390
],
[
45... | [
[
142,
303,
259,
329
],
[
266,
303,
441,
329
],
[
142,
341,
254,
359
],
[
294,
341,
367,
359
],
[
157,
372,
210,
390
],
[
309,
372,
385,
390
],
[
389,
372,
446,
390
],
[
45... |
Lantus: Solostar Half unit syringe; whole unit syringe for Lantus doses > 30 units Duration of 6 months (comparative main 16 (2 x 8 weeks) treatment study period) 6 months comparative extension period* Number of patients HOE901-U300; 274 HOE901-U300; 30 randomised Lantus; 275 Lantus; 29 *Extension period ongoing at the... | Lantus: Solostar Half unit syringe; whole unit syringe for Lantus doses > 30 units Duration of treatment 6 months (comparative main study period) 6 months comparative extension period* 16 (2 x 8 weeks) Number of patients randomised HOE901-U300; 274 Lantus; 275 HOE901-U300; 30 Lantus; 29 *Extension period ongoing at the... | 0.68354 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
25,
16,
17,
18,
19,
26,
27,
28,
29,
30,
31,
32,
20,
21,
22,
23,
24,
33,
34,
35,
40,
36,
37,
41,
42,
38,
39,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-insulin-glargine-rbe-170106-cer.docx | task-634-482 | 17 | [
[
322,
142,
376,
158
],
[
379,
142,
438,
158
],
[
596,
142,
626,
158
],
[
629,
142,
658,
158
],
[
662,
142,
720,
158
],
[
723,
142,
767,
158
],
[
771,
142,
800,
158
],
[
80... | [
[
322,
142,
376,
158
],
[
379,
142,
438,
158
],
[
596,
142,
626,
158
],
[
629,
142,
658,
158
],
[
662,
142,
720,
158
],
[
723,
142,
767,
158
],
[
771,
142,
800,
158
],
[
80... |
these proposed additional risk assessment, were considered minimisation activities. This is due adequate for monitoring the safety to the under reporting and the lack concerns. As a consequence the of reliable exposure (usage) data tools and the plan to provide a associated with spontaneous specific 6 monthly safety fo... | these proposed additional risk minimisation activities. This is due to the under reporting and the lack of reliable exposure (usage) data associated with spontaneous reporting systems, not to mention the information gained from adverse reaction reporting is often incomplete. Consequently the sponsor should plan appropr... | 0.795132 | [
0,
1,
2,
3,
7,
8,
9,
10,
11,
17,
18,
19,
20,
21,
22,
23,
29,
30,
31,
32,
33,
41,
42,
43,
49,
50,
51,
52,
53,
60,
61,
62,
63,
69,
70,
71,
72,
73,
82,
83,
84,
90,
91,
92,
93,
99,
100,
101,
102,
103,
109,
110,
111,
... | auspar-insulin-glargine-rbe-170106.docx | task-634-484 | 21 | [
[
142,
92,
177,
107
],
[
180,
92,
242,
107
],
[
245,
92,
311,
107
],
[
314,
92,
339,
107
],
[
386,
92,
464,
107
],
[
467,
92,
500,
107
],
[
503,
92,
575,
107
],
[
142,
... | [
[
142,
92,
177,
107
],
[
180,
92,
242,
107
],
[
245,
92,
311,
107
],
[
314,
92,
339,
107
],
[
142,
107,
228,
121
],
[
231,
107,
293,
121
],
[
296,
107,
324,
121
],
[
327,
... |
Subgroup aged < 65 years 1.42 0.197 Subgroup aged 65 years 1.12 Subgroup aged < 70 years 1.33 0.355 Subgroup aged 70 years 1.11 Symptomatic bradycardia Overall study population 5.46 Subgroup aged < 65 years 6.64 0.352 Subgroup aged 65 years 4.53 Subgroup aged < 70 years 5.62 0.800 Subgroup aged 70 years 5.07 Asymptomat... | Subgroup aged < 65 years Subgroup aged 65 years 1.42 1.12 0.197 Subgroup aged < 70 years Subgroup aged 70 years 1.33 1.11 0.355 Symptomatic bradycardia Overall study population 5.46 Subgroup aged < 65 years Subgroup aged 65 years 6.64 4.53 0.352 Subgroup aged < 70 years Subgroup aged 70 years 5.62 5.07 0.800 Asymptomat... | 0.837295 | [
0,
1,
2,
3,
4,
7,
8,
9,
10,
5,
11,
6,
12,
13,
14,
15,
16,
19,
20,
21,
22,
17,
23,
18,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
37,
38,
39,
40,
35,
41,
36,
42,
43,
44,
45,
46,
49,
50,
51,
52,
47,
53,
48,
54... | auspar-ivabradine-121031.docx | task-634-493 | 49 | [
[
157,
98,
226,
114
],
[
230,
98,
264,
114
],
[
268,
98,
277,
114
],
[
281,
98,
299,
114
],
[
303,
98,
342,
114
],
[
402,
98,
433,
114
],
[
643,
98,
683,
114
],
[
157,
... | [
[
157,
98,
226,
114
],
[
230,
98,
264,
114
],
[
268,
98,
277,
114
],
[
281,
98,
299,
114
],
[
303,
98,
342,
114
],
[
157,
119,
226,
136
],
[
230,
119,
264,
136
],
[
271,
... |
For both conventions, subjects who completed the study or who had not relapsed were considered as censored. Numbers of subjects (%) who discontinued prematurely are given in Table 19 below, with reasons. Table 19. Study RD.03.SRE.40037. Numbers of subjects (%) who discontinued prematurely. Ivermectin 0.1% 0.3% 1% 1% BD... | For both conventions, subjects who completed the study or who had not relapsed were considered as censored. Numbers of subjects (%) who discontinued prematurely are given in Table 19 below, with reasons. Table 19. Study RD.03.SRE.40037. Numbers of subjects (%) who discontinued prematurely. Ivermectin 0.1% daily 0.3% da... | 0.659814 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
51,
45,
52,
46,
53,
47,
48,
49,
54,
50... | auspar-ivermectin-151209-cer_0.docx | task-634-500 | 30 | [
[
120,
89,
148,
107
],
[
152,
89,
188,
107
],
[
192,
89,
292,
107
],
[
296,
89,
361,
107
],
[
365,
89,
399,
107
],
[
403,
89,
486,
107
],
[
490,
89,
516,
107
],
[
520,
... | [
[
120,
89,
148,
107
],
[
152,
89,
188,
107
],
[
192,
89,
292,
107
],
[
296,
89,
361,
107
],
[
365,
89,
399,
107
],
[
403,
89,
486,
107
],
[
490,
89,
516,
107
],
[
520,
... |
FDA 16-Jul-2012 17-Sep-2012 Confirmatory sample The SAPs for container Errors in treatment were low (20%). label analysis and the and consistent across sensitivity analyses are treatment arms, indicating a 3 major sets of analysis presented in Appendix 2. well-controlled process. Container labels. FDA provided sponsors... | FDA 16-Jul-2012 17-Sep-2012 Confirmatory sample (20%). 3 major sets of analysis Container labels. eCRF data entries relative to IVRS assignments. Sensitivity analyses on simulated medication error frequencies for the ARISTOTLE conclusions. The SAPs for container label analysis and the sensitivity analyses are presented... | 0.530502 | [
0,
1,
2,
3,
4,
14,
29,
30,
31,
32,
33,
40,
41,
47,
48,
49,
59,
60,
61,
70,
84,
85,
86,
96,
97,
102,
103,
104,
105,
106,
107,
5,
6,
7,
8,
15,
16,
17,
18,
22,
23,
24,
34,
35,
36,
37,
42,
43,
44,
50,
51,
52,
53,
5... | auspar-apixaban-130621-cer.docx | task-634-51 | 43 | [
[
85,
219,
107,
242
],
[
150,
219,
211,
242
],
[
235,
219,
300,
242
],
[
340,
219,
408,
242
],
[
411,
219,
447,
242
],
[
517,
219,
536,
242
],
[
539,
219,
564,
242
],
[
567... | [
[
85,
219,
107,
242
],
[
150,
219,
211,
242
],
[
235,
219,
300,
242
],
[
340,
219,
408,
242
],
[
411,
219,
447,
242
],
[
340,
239,
375,
262
],
[
340,
269,
347,
292
],
[
349... |
AUC Area under the plasma/serum/PBMC concentration versus time curve AUCtau Area under the plasma/serum/PBMC concentration versus time curve over the dosing interval BA Bioavailability BCRP Breast cancer resistance protein BCS Biopharmaceutics Classification System BID daily BMI Body mass index BOC Boceprevir BSEP Bile... | AUC Area under the plasma/serum/PBMC concentration versus time curve AUCtau Area under the plasma/serum/PBMC concentration versus time curve over the dosing interval BA Bioavailability BCRP Breast cancer resistance protein BCS Biopharmaceutics Classification System BID daily BMI Body mass index BOC Boceprevir BSEP Bile... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-ledipasvir-sofosbuvir-151008-cer.docx | task-634-517 | 5 | [
[
135,
128,
169,
146
],
[
311,
128,
348,
146
],
[
352,
128,
399,
146
],
[
403,
128,
429,
146
],
[
433,
128,
605,
146
],
[
609,
128,
719,
146
],
[
723,
128,
775,
146
],
[
77... | [
[
135,
128,
169,
146
],
[
311,
128,
348,
146
],
[
352,
128,
399,
146
],
[
403,
128,
429,
146
],
[
433,
128,
605,
146
],
[
609,
128,
719,
146
],
[
723,
128,
775,
146
],
[
77... |
Provide the proposed educational A general outline of the proposed CME program was provided in The sponsor has not provided a copy of the draft materials to the Office of Product the Sponsor’s response. educational materials with their response or Review (OPR) prior to marketing and details on the knowledge and trainin... | Provide the proposed educational materials to the Office of Product Review (OPR) prior to marketing and additional detail on how they will be implemented. That is, which representatives from the sponsor will deliver face to face activities and how will the sponsor ensure they have the appropriate training/knowledge. In... | 0.767563 | [
0,
1,
2,
3,
25,
26,
27,
28,
29,
30,
40,
41,
42,
43,
44,
45,
54,
55,
56,
57,
58,
59,
60,
65,
66,
67,
68,
77,
78,
79,
80,
81,
89,
90,
91,
92,
93,
94,
95,
97,
98,
99,
100,
101,
102,
103,
110,
111,
112,
122,
123,
124,
... | auspar-linagliptin-metformin-130926.docx | task-634-545 | 33 | [
[
40,
173,
83,
198
],
[
86,
173,
104,
198
],
[
107,
173,
160,
198
],
[
163,
173,
228,
198
],
[
295,
173,
303,
198
],
[
306,
173,
348,
198
],
[
351,
173,
390,
198
],
[
393,
... | [
[
40,
173,
83,
198
],
[
86,
173,
104,
198
],
[
107,
173,
160,
198
],
[
163,
173,
228,
198
],
[
44,
195,
97,
220
],
[
100,
195,
111,
220
],
[
114,
195,
132,
220
],
[
135,
... |
LDX 4 weeks 3 240 4 (week 4 data) 6 432 7 12 1073 18 Rat (SD) d-amphetamine Juvenile 8 weeks 4 402 0.2 (data are for 10 1021 0.5 PPD 7 and PPD 63) 40 4638 2.2 LDX 8 weeks 4 29 0.3 (data are for 10 126 1.2 PPD 7 and PPD 63) 40 597 5 Dog d-amphetamine (Beagle) 6 months 2 0.2 445♦ Juvenile (6 data) 5 0.5 1151♦ 12 1.5 3202... | LDX 4 weeks (week 4 data) 3 240 4 6 432 7 12 1073 18 Rat (SD) Juvenile d-amphetamine 8 weeks (data are for PPD 7 and PPD 63) 4 402 0.2 10 1021 0.5 40 4638 2.2 LDX 8 weeks (data are for PPD 7 and PPD 63) 4 29 0.3 10 126 1.2 40 597 5 Dog (Beagle) Juvenile d-amphetamine 6 months (6 data) 2 445♦ 0.2 5 1151♦ 0.5 12 3202♦ 1.... | 0.396839 | [
0,
1,
2,
6,
7,
8,
3,
4,
5,
9,
10,
11,
12,
13,
14,
15,
16,
18,
17,
19,
20,
24,
25,
26,
30,
31,
32,
33,
34,
21,
22,
23,
27,
28,
29,
35,
36,
37,
38,
39,
40,
44,
45,
46,
50,
51,
52,
53,
54,
41,
42,
43,
47,
48,
49... | auspar-lisdexamfetamine-dimesilate-131023.docx | task-634-553 | 24 | [
[
261,
142,
293,
158
],
[
261,
172,
271,
188
],
[
274,
172,
320,
188
],
[
416,
172,
426,
188
],
[
559,
172,
587,
188
],
[
702,
172,
711,
188
],
[
261,
193,
306,
209
],
[
31... | [
[
261,
142,
293,
158
],
[
261,
172,
271,
188
],
[
274,
172,
320,
188
],
[
261,
193,
306,
209
],
[
310,
193,
319,
209
],
[
323,
193,
360,
209
],
[
416,
172,
426,
188
],
[
55... |
treated for at least 100 EDs. Subjects received a total of 5,313 injections with a median of 59 (range 4 to 145 injections per subject). Control and prevention of bleeding episodes Adult and adolescent subjects (≥12 to 65 years of age) In the adult/adolescent study a total of 848 bleeding episodes were treated with AFS... | treated for at least 100 EDs. Subjects received a total of 5,313 injections with a median of 59 (range 4 to 145 injections per subject). Control and prevention of bleeding episodes Adult and adolescent subjects (≥12 to 65 years of age) In the adult/adolescent study a total of 848 bleeding episodes were treated with AFS... | 0.980948 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-lonoctocog-alfa-rch-180123-pi.docx | task-634-561 | 4 | [
[
120,
113,
175,
132
],
[
180,
113,
204,
132
],
[
209,
113,
223,
132
],
[
228,
113,
265,
132
],
[
270,
113,
300,
132
],
[
305,
113,
345,
132
],
[
350,
113,
418,
132
],
[
42... | [
[
120,
113,
175,
132
],
[
180,
113,
204,
132
],
[
209,
113,
223,
132
],
[
228,
113,
265,
132
],
[
270,
113,
300,
132
],
[
305,
113,
345,
132
],
[
350,
113,
418,
132
],
[
42... |
Pulmonary embolism Respiratory, thoracic and Dyspnoea Pleural effusion mediastinal disorders Cough Rhinorrhoea Dysphonia Oropharyngeal pain Epistaxis Enterocolitis haemorrhagic Gastrointestinal disorders Abdominal pain Gastrointestinal haemorrhage Constipation Pancreatitis Stomatitis Ascites Oral disorder Ileus Subileu... | Respiratory, thoracic and mediastinal disorders Dyspnoea Cough Pulmonary embolism Pleural effusion Rhinorrhoea Dysphonia Oropharyngeal pain Epistaxis Gastrointestinal disorders Abdominal pain Constipation Stomatitis Oral disorder Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis Ascites Ileus Subileu... | 0.570518 | [
2,
3,
4,
8,
9,
5,
10,
0,
1,
6,
7,
11,
12,
13,
14,
15,
18,
19,
20,
21,
24,
26,
28,
29,
16,
17,
22,
23,
25,
27,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-lonsurf-180612-pi.docx | task-634-563 | 12 | [
[
607,
148,
695,
166
],
[
700,
148,
779,
166
],
[
95,
155,
203,
173
],
[
208,
155,
280,
173
],
[
285,
155,
318,
173
],
[
393,
155,
476,
173
],
[
607,
163,
664,
181
],
[
669... | [
[
95,
155,
203,
173
],
[
208,
155,
280,
173
],
[
285,
155,
318,
173
],
[
95,
170,
197,
188
],
[
202,
170,
286,
188
],
[
393,
155,
476,
173
],
[
393,
170,
447,
188
],
[
607,... |
Attachment 1. Product Information The PI for Orkambi 200/125 approved with the submission which is described in this AusPAR is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report | Attachment 1. Product Information The PI for Orkambi 200/125 approved with the submission which is described in this AusPAR is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43
] | auspar-lumacaftor-ivacaftor-160908.docx | task-634-567 | 79 | [
[
142,
88,
290,
114
],
[
298,
88,
320,
114
],
[
327,
88,
429,
114
],
[
436,
88,
584,
114
],
[
142,
118,
172,
136
],
[
177,
118,
193,
136
],
[
197,
118,
220,
136
],
[
224,
... | [
[
142,
88,
290,
114
],
[
298,
88,
320,
114
],
[
327,
88,
429,
114
],
[
436,
88,
584,
114
],
[
142,
118,
172,
136
],
[
177,
118,
193,
136
],
[
197,
118,
220,
136
],
[
224,
... |
GCP Good Clinical Practice GFR Glomerular filtration rate Hgb Haemoglobin HR Hazard HRA/T Hazard ratio of ABI-007/carboplatin to Taxol/carboplatin ICH International Conference on Harmonisation IEC Independent Ethics Committee IRB Institutional Review Board ITT Intent-to-treat IV Intravenous IVR Interactive voice respon... | GCP Good Clinical Practice GFR Glomerular filtration rate Hgb Haemoglobin HR Hazard HRA/T Hazard ratio of ABI-007/carboplatin to Taxol/carboplatin ICH International Conference on Harmonisation IEC Independent Ethics Committee IRB Institutional Review Board ITT Intent-to-treat IV Intravenous IVR Interactive voice respon... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-nab-paclitaxet-140109-cer.docx | task-634-614 | 6 | [
[
135,
128,
167,
146
],
[
299,
128,
340,
146
],
[
344,
128,
402,
146
],
[
406,
128,
470,
146
],
[
135,
159,
167,
177
],
[
299,
159,
389,
177
],
[
393,
159,
463,
177
],
[
46... | [
[
135,
128,
167,
146
],
[
299,
128,
340,
146
],
[
344,
128,
402,
146
],
[
406,
128,
470,
146
],
[
135,
159,
167,
177
],
[
299,
159,
389,
177
],
[
393,
159,
463,
177
],
[
46... |
4. Tyrosine kinase Oncology The sponsor’s inhibitors are seen as response is Several angiogenesis promising treatment acceptable. inhibitors, such as options for different types bevacizumab, sunitinib and of solid tumours. Trial sorafenib are currently 1199.15 U09-1763 is an approved for the treatment of example of inv... | 4. Tyrosine kinase inhibitors are seen as promising treatment options for different types of solid tumours. Trial 1199.15 U09-1763 is an example of investigating nintedanib for the treatment of ovarian cancer. In addition, clinical trials are also underway to investigate the combination treatment of nintedanib with dru... | 0.7055 | [
0,
1,
2,
6,
7,
8,
9,
14,
15,
20,
21,
22,
23,
27,
28,
29,
30,
34,
35,
36,
37,
43,
44,
45,
51,
52,
53,
56,
57,
58,
64,
65,
66,
67,
72,
73,
74,
75,
76,
81,
82,
86,
87,
88,
93,
94,
95,
98,
99,
100,
105,
106,
107,
1... | auspar-nintedanib-esilate-160208.docx | task-634-634 | 55 | [
[
157,
97,
171,
115
],
[
175,
97,
245,
115
],
[
249,
97,
300,
115
],
[
416,
97,
489,
115
],
[
702,
97,
732,
115
],
[
736,
97,
811,
115
],
[
157,
113,
234,
131
],
[
238,
... | [
[
157,
97,
171,
115
],
[
175,
97,
245,
115
],
[
249,
97,
300,
115
],
[
157,
113,
234,
131
],
[
238,
113,
264,
131
],
[
268,
113,
304,
131
],
[
308,
113,
325,
131
],
[
157,
... |
13. Life Quality Index Questionnaire: Observed Values at Visits 0, 6 and 12, Safety Population For quality of life analyses, a total of 7 paediatric patients aged between 8 and 16 completed the CHQ-PF50™ questionnaire at least once during the study. However, only three completed questionnaires at all three time points ... | 13. Life Quality Index Questionnaire: Observed Values at Visits 0, 6 and 12, Safety Population For quality of life analyses, a total of 7 paediatric patients aged between 8 and 16 completed the CHQ-PF50™ questionnaire at least once during the study. However, only three completed questionnaires at all three time points ... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-normal-immunoglobulin-human-120507.docx | task-634-656 | 19 | [
[
184,
99,
208,
116
],
[
211,
99,
240,
116
],
[
244,
99,
300,
116
],
[
304,
99,
348,
116
],
[
351,
99,
466,
116
],
[
470,
99,
544,
116
],
[
548,
99,
599,
116
],
[
603,
... | [
[
184,
99,
208,
116
],
[
211,
99,
240,
116
],
[
244,
99,
300,
116
],
[
304,
99,
348,
116
],
[
351,
99,
466,
116
],
[
470,
99,
544,
116
],
[
548,
99,
599,
116
],
[
603,
... |
HCR Haematological complete remission IDA Idarubicin ITT Intention-to-treat IV Intravenous mRNA Messenger ribonucleic acid MTX Methotrexate NCCN National Comprehensive Cancer Network NCI National Cancer Institute ND Not done OS Overall survival PML-RARα Promyelocytic leukaemia retinoic acid receptor alpha fusion gene –... | HCR Haematological complete remission IDA Idarubicin ITT Intention-to-treat IV Intravenous mRNA Messenger ribonucleic acid MTX Methotrexate NCCN National Comprehensive Cancer Network NCI National Cancer Institute ND Not done OS Overall survival PML-RARα Promyelocytic leukaemia – retinoic acid receptor alpha fusion gene... | 0.952405 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
40,
34,
35,
36,
37,
38,
39,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-arsenic-trioxide-151216.docx | task-634-68 | 5 | [
[
157,
97,
191,
115
],
[
322,
97,
444,
115
],
[
448,
97,
521,
115
],
[
525,
97,
603,
115
],
[
157,
128,
186,
146
],
[
322,
128,
403,
146
],
[
157,
159,
185,
177
],
[
322,
... | [
[
157,
97,
191,
115
],
[
322,
97,
444,
115
],
[
448,
97,
521,
115
],
[
525,
97,
603,
115
],
[
157,
128,
186,
146
],
[
322,
128,
403,
146
],
[
157,
159,
185,
177
],
[
322,
... |
Haematological disorders including leucocytosis, haemorrhage, thrombosis (common). 5. The sponsor states: The sponsor has included The evaluator has noted the carcinogenicity as potential risks change to the updated studies have ‘Epidemiological to the RMP. The sponsor’s response found considerable evidence is satisfac... | Haematological disorders including leucocytosis, haemorrhage, thrombosis (common). 5. The sponsor states: ‘Epidemiological studies have found considerable evidence for an association between arsenic exposure and increased incidence of tumours, especially of the skin, lung and some internal organs. The mechanism of acti... | 0.698477 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
30,
28,
29,
37,
38,
39,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54,
55,
56,
57,
58,
59,
60,
61,
62,
63,
64,
65,
66,
67,
68,
69,
70,
71,
72,
73,
74,
75,
76,
77,
78,
79... | auspar-arsenic-trioxide-151216.docx | task-634-68 | 28 | [
[
142,
91,
254,
107
],
[
257,
91,
326,
107
],
[
142,
105,
209,
121
],
[
213,
105,
304,
121
],
[
142,
119,
242,
136
],
[
246,
119,
328,
136
],
[
142,
134,
221,
150
],
[
142,... | [
[
142,
91,
254,
107
],
[
257,
91,
326,
107
],
[
142,
105,
209,
121
],
[
213,
105,
304,
121
],
[
142,
119,
242,
136
],
[
246,
119,
328,
136
],
[
142,
134,
221,
150
],
[
142,... |
2012) as found on the states: ASA, has any differences between ‘The TGA website, when an been updated to the content and wording existing European Union incorporate the RMP of the EU SmPC and the (EU) RMP is available, evaluator’s proposed Australian PI the TGA strongly recommendations.’ for all of the specified recomm... | 2012) as found on the TGA website, when an existing European Union (EU) RMP is available, the TGA strongly recommends submission of the EU-RMP with an ASA. These guidelines also state: ‘The ASA should identify any differences between the EU-RMP and the local implementation of risk management activities, for example: an... | 0.668635 | [
0,
1,
2,
3,
4,
12,
13,
14,
15,
23,
24,
25,
35,
36,
37,
38,
43,
44,
45,
52,
53,
57,
58,
59,
60,
61,
67,
68,
69,
73,
74,
79,
75,
80,
81,
82,
86,
87,
88,
92,
93,
94,
95,
100,
101,
102,
104,
105,
106,
107,
108,
109,
... | auspar-omalizumab-rch-150721.docx | task-634-683 | 20 | [
[
157,
90,
205,
108
],
[
209,
90,
226,
108
],
[
230,
90,
276,
108
],
[
280,
90,
300,
108
],
[
304,
90,
329,
108
],
[
401,
90,
452,
108
],
[
493,
90,
527,
108
],
[
531,
... | [
[
157,
90,
205,
108
],
[
209,
90,
226,
108
],
[
230,
90,
276,
108
],
[
280,
90,
300,
108
],
[
304,
90,
329,
108
],
[
157,
106,
190,
124
],
[
194,
106,
260,
124
],
[
264,
... |
2 additional subjects in the 525 mg equivalent gluteal group had a post baseline QTcB > 480 msec and < 500 msec (Day 224 for one subject, EOS visit for other subject). 1 subject in the 350 mg equivalent gluteal had a change of > 60 ms in QTcB and QTcF from baseline (on Day 224). Injection site reactions None of them we... | 2 additional subjects in the 525 mg equivalent gluteal group had a post baseline QTcB > 480 msec and < 500 msec (Day 224 for one subject, EOS visit for other subject). 1 subject in the 350 mg equivalent gluteal had a change of > 60 ms in QTcB and QTcF from baseline (on Day 224). Injection site reactions None of them we... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-paliperidone-palmitate-171013-cer_0.docx | task-634-696 | 56 | [
[
151,
79,
161,
97
],
[
165,
79,
245,
97
],
[
249,
79,
314,
97
],
[
318,
79,
333,
97
],
[
337,
79,
363,
97
],
[
367,
79,
397,
97
],
[
401,
79,
426,
97
],
[
430,
79,
... | [
[
151,
79,
161,
97
],
[
165,
79,
245,
97
],
[
249,
79,
314,
97
],
[
318,
79,
333,
97
],
[
337,
79,
363,
97
],
[
367,
79,
397,
97
],
[
401,
79,
426,
97
],
[
430,
79,
... |
CYP2C8 Reversible Not anticipated (R-value 1.0160); lack of inhibitor; safety signals in patients taking loperamide IC50 = 13 and zopiclone µM CYP3A4 Minimally Unlikely to be relevant based on induced with ritonavir (see below) (approx.. one the effect of rifampin) UGT1A1 IC50 = 3.6 Unlikely (clinical showed 34% decrea... | CYP2C8 Reversible inhibitor; IC50 = 13 µM Not anticipated (R-value 1.0160); lack of safety signals in patients taking loperamide and zopiclone CYP3A4 Minimally induced (approx.. one the effect of rifampin) Unlikely to be relevant based on with ritonavir (see below) UGT1A1 IC50 = 3.6 µM Unlikely (clinical showed 34% dec... | 0.763608 | [
0,
1,
8,
15,
16,
17,
20,
2,
3,
4,
5,
6,
7,
9,
10,
11,
12,
13,
14,
18,
19,
21,
22,
29,
34,
35,
36,
37,
38,
39,
23,
24,
25,
26,
27,
28,
30,
31,
32,
33,
40,
41,
42,
43,
49,
44,
45,
46,
47,
48,
50,
51,
52,
53,
54... | auspar-paritaprevir-ritonavir-ombitasvir-dasabuvir-as-sodium-salt-and-ribavirin-170324.docx | task-634-707 | 69 | [
[
262,
135,
319,
151
],
[
376,
135,
452,
151
],
[
518,
135,
544,
151
],
[
548,
135,
628,
151
],
[
632,
135,
693,
151
],
[
697,
135,
757,
151
],
[
761,
135,
790,
151
],
[
79... | [
[
262,
135,
319,
151
],
[
376,
135,
452,
151
],
[
376,
149,
444,
165
],
[
376,
163,
410,
180
],
[
413,
163,
423,
180
],
[
426,
163,
445,
180
],
[
376,
177,
399,
194
],
[
51... |
22: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned Actions/outcome safety proposed concern of data Phase II/III Study HIV Assess safety of Phase II M14-004, "A cohort Randomized, subjects and dasabuvir in 3Q label Study to Evaluate with RBV for 2014 the Safety and Efficacy 1... | 22: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned safety concern Actions/outcome proposed of data Phase II/III Study M14-004, "A Randomized, Study to Evaluate the Safety and Efficacy of and dasabuvir with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (... | 0.488295 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
12,
14,
11,
13,
15,
16,
17,
18,
19,
26,
27,
29,
36,
37,
38,
43,
44,
45,
46,
54,
74,
81,
85,
89,
90,
91,
97,
98,
99,
104,
105,
106,
107,
112,
113,
114,
120,
121,
124,
126,
127,
12... | auspar-paritaprevir-ritonavir-ombitasvir-dasabuvir-as-sodium-salt-and-ribavirin-170324.docx | task-634-707 | 104 | [
[
188,
89,
215,
107
],
[
219,
89,
309,
107
],
[
313,
89,
475,
107
],
[
479,
89,
557,
107
],
[
561,
89,
630,
107
],
[
634,
89,
655,
107
],
[
659,
89,
687,
107
],
[
691,
... | [
[
188,
89,
215,
107
],
[
219,
89,
309,
107
],
[
313,
89,
475,
107
],
[
479,
89,
557,
107
],
[
561,
89,
630,
107
],
[
634,
89,
655,
107
],
[
659,
89,
687,
107
],
[
691,
... |
55 year old Sepsis/Grade 4 Not OT drug White female Septic Shock/Grade related Week 24 interrupted, 4 treatment Duration: 5 required days 53 year old Related OT Study drug White female b/ Grade 3 Week 10 discontinued, treatment not ALT Increased Duration: 4 required b/Grade 3 days AST Increased 4 Placebo Group 50 year ... | 55 year old White female Sepsis/Grade 4 Septic Shock/Grade 4 Not related OT Week 24 Duration: 5 days drug interrupted, treatment required 53 year old White female b/ Grade 3 ALT Increased b/Grade 3 AST Increased 4 Related OT Week 10 Duration: 4 days Study drug discontinued, treatment not required Placebo Group 50 year ... | 0.70084 | [
0,
1,
2,
8,
9,
3,
4,
10,
11,
16,
5,
12,
6,
13,
14,
18,
19,
21,
7,
15,
17,
20,
22,
23,
24,
29,
30,
31,
32,
33,
39,
40,
44,
45,
47,
48,
49,
25,
26,
34,
35,
41,
42,
46,
27,
28,
36,
37,
38,
43,
50,
51,
52,
53,
54... | auspar-asunaprevir-151214-cer.docx | task-634-72 | 39 | [
[
135,
189,
155,
207
],
[
159,
189,
194,
207
],
[
198,
189,
223,
207
],
[
287,
189,
392,
207
],
[
396,
189,
407,
207
],
[
489,
189,
518,
207
],
[
655,
189,
678,
207
],
[
80... | [
[
135,
189,
155,
207
],
[
159,
189,
194,
207
],
[
198,
189,
223,
207
],
[
135,
205,
182,
223
],
[
186,
205,
239,
223
],
[
287,
189,
392,
207
],
[
396,
189,
407,
207
],
[
28... |
Patients should be study treatment after an by the RMP evaluator to treated with Keytruda initial disease more clearly define until disease assessment of disease progression, and progression or progression until a to consider the unacceptable toxicity. second disease acceptability of the Atypical responses (that assess... | Patients should be treated with Keytruda until disease progression or unacceptable toxicity. Atypical responses (that is, an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Clinical stable patients with initial evidence of dise... | 0.490793 | [
0,
1,
2,
12,
13,
14,
20,
21,
27,
28,
35,
36,
42,
43,
44,
52,
53,
54,
55,
62,
63,
64,
65,
74,
75,
76,
77,
83,
84,
85,
86,
95,
96,
97,
104,
105,
106,
113,
114,
115,
124,
125,
126,
134,
135,
136,
144,
145,
153,
154,
155... | auspar-pembrolizumab-rch-161014.docx | task-634-723 | 40 | [
[
157,
90,
221,
108
],
[
225,
90,
278,
108
],
[
282,
90,
302,
108
],
[
401,
90,
445,
108
],
[
449,
90,
528,
108
],
[
532,
90,
569,
108
],
[
573,
90,
593,
108
],
[
645,
... | [
[
157,
90,
221,
108
],
[
225,
90,
278,
108
],
[
282,
90,
302,
108
],
[
157,
106,
214,
124
],
[
218,
106,
254,
124
],
[
258,
106,
331,
124
],
[
157,
121,
194,
139
],
[
198,
... |
Table . Demography and Baseline Characteristics by Modal Dose of Perampanel and < 18y Age Group - All Treated Subjects with Partial Seizures (Safety Analysis Set) a: Subjects treated with placebo during the double-blind study. b: Subjects treated with perampanel in any study. Dose is the modal dose received. c: Not col... | Table . Demography and Baseline Characteristics by Modal Dose of Perampanel and < 18y Age Group - All Treated Subjects with Partial Seizures (Safety Analysis Set) a: Subjects treated with placebo during the double-blind study. b: Subjects treated with perampanel in any study. Dose is the modal dose received. c: Not col... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-perampanel-141014-cer.docx | task-634-728 | 96 | [
[
67,
119,
98,
142
],
[
100,
119,
103,
142
],
[
106,
119,
176,
142
],
[
179,
119,
199,
142
],
[
202,
119,
249,
142
],
[
251,
119,
333,
142
],
[
336,
119,
349,
142
],
[
352,... | [
[
67,
119,
98,
142
],
[
100,
119,
103,
142
],
[
106,
119,
176,
142
],
[
179,
119,
199,
142
],
[
202,
119,
249,
142
],
[
251,
119,
333,
142
],
[
336,
119,
349,
142
],
[
352,... |
I. Introduction to product submission Submission details Type of submission: New biological entity Decision: Approved Date of decision: 24 February 2017 Date of onto ARTG 7 March 2017 Active ingredient: Phleum pratense Product name: Grazax Sponsor’s name and address: Seqirus Pty Ltd 63 Poplar Rd Parkville Vic 3052 Dose... | I. Introduction to product submission Submission details Type of submission: New biological entity Decision: Approved Date of decision: 24 February 2017 Date of onto ARTG 7 March 2017 Active ingredient: Phleum pratense Product name: Grazax Sponsor’s name and address: Seqirus Pty Ltd 63 Poplar Rd Parkville Vic 3052 Dose... | 0.990437 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-phleum-pratense-180403.docx | task-634-737 | 8 | [
[
142,
102,
157,
129
],
[
165,
102,
321,
129
],
[
329,
102,
354,
129
],
[
361,
102,
461,
129
],
[
469,
102,
618,
129
],
[
142,
139,
266,
160
],
[
272,
139,
341,
160
],
[
15... | [
[
142,
102,
157,
129
],
[
165,
102,
321,
129
],
[
329,
102,
354,
129
],
[
361,
102,
461,
129
],
[
469,
102,
618,
129
],
[
142,
139,
266,
160
],
[
272,
139,
341,
160
],
[
15... |
Fatigue was more common with pirfenidone (26% versus 19%), however generally benign and reported in the 9 months. It is identified in the PI under Adverse events. Of note, in the EU EMA SPC, dizziness and fatigue are mentioned as potentially influencing ability to drive or operate machinery. Anorexia was more common wi... | Fatigue was more common with pirfenidone (26% versus 19%), however generally benign and reported in the 9 months. It is identified in the PI under Adverse events. Of note, in the EU EMA SPC, dizziness and fatigue are mentioned as potentially influencing ability to drive or operate machinery. Anorexia was more common wi... | 0.985324 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-pirfenidone-160809-cer.docx | task-634-738 | 42 | [
[
120,
89,
179,
107
],
[
183,
89,
214,
107
],
[
218,
89,
260,
107
],
[
264,
89,
333,
107
],
[
337,
89,
373,
107
],
[
377,
89,
469,
107
],
[
473,
89,
517,
107
],
[
521,
... | [
[
120,
89,
179,
107
],
[
183,
89,
214,
107
],
[
218,
89,
260,
107
],
[
264,
89,
333,
107
],
[
337,
89,
373,
107
],
[
377,
89,
469,
107
],
[
473,
89,
517,
107
],
[
521,
... |
Information (PI) about the prevention of nasopharyngeal carriage of S. pneumoniae serotypes. Regulatory status The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on 29 March 2010. An extension of indication (EOI) to include children and adolescents aged 6-17 years was approved in ... | Information (PI) about the prevention of nasopharyngeal carriage of S. pneumoniae serotypes. Regulatory status The product received initial Australian Register of Therapeutic Goods (ARTG) Registration on 29 March 2010. An extension of indication (EOI) to include children and adolescents aged 6-17 years was approved in ... | 0.885218 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-pneumococcal-polysaccharide-conjugate-vaccine-140207.docx | task-634-746 | 7 | [
[
142,
89,
238,
107
],
[
242,
89,
272,
107
],
[
276,
89,
322,
107
],
[
326,
89,
351,
107
],
[
355,
89,
442,
107
],
[
446,
89,
462,
107
],
[
466,
89,
592,
107
],
[
596,
... | [
[
142,
89,
238,
107
],
[
242,
89,
272,
107
],
[
276,
89,
322,
107
],
[
326,
89,
351,
107
],
[
355,
89,
442,
107
],
[
446,
89,
462,
107
],
[
466,
89,
592,
107
],
[
596,
... |
condition of registration. For the important The sponsor stated that the This was identified risk Prevenar 13 Core Data Sheet has considered to rates recently been updated to include be acceptable ‘Increased when 13vPnC is information regarding the and the concomitant administration of Delegate was Infanrix hexa’, it w... | condition of registration. For the important identified risk ‘Increased rates when 13vPnC is Infanrix hexa’, it was recommended that the sponsor propose adequate and appropriate risk minimisation activities as found in the EU SmPC. It is important to inform Healthcare Professionals of the risk of higher rates of febril... | 0.54731 | [
0,
1,
2,
3,
4,
5,
13,
14,
31,
23,
32,
33,
34,
45,
46,
47,
48,
55,
56,
65,
66,
67,
74,
75,
86,
87,
93,
101,
102,
103,
104,
111,
112,
113,
114,
115,
122,
123,
124,
131,
136,
137,
138,
139,
140,
141,
142,
143,
144,
145,
... | auspar-pneumococcal-polysaccharide-conjugate-vaccine-140207.docx | task-634-746 | 23 | [
[
178,
152,
253,
170
],
[
257,
152,
273,
170
],
[
178,
167,
275,
185
],
[
178,
198,
205,
216
],
[
209,
198,
235,
216
],
[
239,
198,
319,
216
],
[
390,
198,
420,
216
],
[
42... | [
[
178,
152,
253,
170
],
[
257,
152,
273,
170
],
[
178,
167,
275,
185
],
[
178,
198,
205,
216
],
[
209,
198,
235,
216
],
[
239,
198,
319,
216
],
[
178,
213,
254,
231
],
[
25... |
(ATP cohort) Type or cause of AOM Vaccine efficacy Clinical AOM episodes regardless of 33.6 % etiology (95% CI: 20.8; 44.3) AOM episodes due to any 51.5% pneumococcal serotype (95% CI: 36.8;62.9) AOM episodes due to pneumococcal 57.6% serotypes covered by the 11Pn-PD (95% CI: 41.4;69.3) vaccine AOM episodes due to pneu... | (ATP cohort) Type or cause of AOM Vaccine efficacy Clinical AOM episodes regardless of etiology 33.6 % (95% CI: 20.8; 44.3) AOM episodes due to any pneumococcal serotype 51.5% (95% CI: 36.8;62.9) AOM episodes due to pneumococcal serotypes covered by the 11Pn-PD vaccine 57.6% (95% CI: 41.4;69.3) AOM episodes due to pneu... | 0.851782 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
16,
14,
15,
17,
18,
19,
20,
21,
22,
23,
24,
25,
27,
28,
26,
29,
30,
31,
32,
33,
34,
35,
36,
38,
39,
40,
41,
42,
46,
37,
43,
44,
45,
47,
48,
49,
50,
51,
53,
54,
55... | auspar-pneumococcal-polysaccharide-vaccine-121022-pi.docx | task-634-747 | 9 | [
[
95,
139,
142,
158
],
[
147,
139,
217,
158
],
[
171,
182,
216,
201
],
[
221,
182,
239,
201
],
[
245,
182,
299,
201
],
[
304,
182,
321,
201
],
[
327,
182,
372,
201
],
[
571... | [
[
95,
139,
142,
158
],
[
147,
139,
217,
158
],
[
171,
182,
216,
201
],
[
221,
182,
239,
201
],
[
245,
182,
299,
201
],
[
304,
182,
321,
201
],
[
327,
182,
372,
201
],
[
571... |
Use (ATU) reports identified as of post-marketing experience”, but actually reports “reports of patients treated in France under a Compassionate Use Program (CUP); literature references. Module 1: Application letter; application forms; proposed Australian Product Information (PI); proposed Australian Consumer Medicine ... | Use (ATU) reports identified as “reports of post-marketing experience”, but actually reports of patients treated in France under a Compassionate Use Program (CUP); literature references. Module 1: Application letter; application forms; proposed Australian Product Information (PI); proposed Australian Consumer Medicine ... | 0.978013 | [
0,
1,
2,
3,
4,
11,
5,
6,
7,
8,
9,
10,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-propranolol-hydrochloride-150819-cer.docx | task-634-765 | 11 | [
[
151,
89,
180,
107
],
[
184,
89,
232,
107
],
[
236,
89,
295,
107
],
[
299,
89,
375,
107
],
[
379,
89,
396,
107
],
[
469,
89,
485,
107
],
[
489,
89,
611,
107
],
[
615,
... | [
[
151,
89,
180,
107
],
[
184,
89,
232,
107
],
[
236,
89,
295,
107
],
[
299,
89,
375,
107
],
[
379,
89,
396,
107
],
[
400,
91,
465,
107
],
[
469,
89,
485,
107
],
[
489,
... |
Copyright © Commonwealth of Australia 2015 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any comm... | Copyright © Commonwealth of Australia 2015 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any comm... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-remestemcel-l-150315.docx | task-634-788 | 2 | [
[
142,
90,
207,
103
],
[
142,
101,
155,
115
],
[
158,
101,
254,
115
],
[
257,
101,
269,
115
],
[
272,
101,
328,
115
],
[
331,
101,
362,
115
],
[
142,
113,
169,
127
],
[
172... | [
[
142,
90,
207,
103
],
[
142,
101,
155,
115
],
[
158,
101,
254,
115
],
[
257,
101,
269,
115
],
[
272,
101,
328,
115
],
[
331,
101,
362,
115
],
[
142,
113,
169,
127
],
[
172... |
justifying inserting it as an important risk in the RMP. Neither study (1889-1 The sponsor acknowledges the The sponsor’s or 1889-2) involved comment and would like to response is Australian patients. provide an update on the satisfactory. However, all findings are aforementioned studies. considered relevant and applic... | justifying inserting it as an important risk in the RMP. Neither study (1889-1 or 1889-2) involved Australian patients. However, all findings are considered relevant and applicable to the local context. The sponsor should provide an update on significant safety findings from Studies1889-1 and 1889-2 (TA-402). The spons... | 0.893506 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
19,
20,
21,
29,
30,
37,
38,
39,
40,
43,
44,
45,
46,
47,
48,
49,
54,
55,
56,
57,
62,
63,
64,
65,
70,
71,
72,
79,
80,
86,
87,
88,
13,
14,
15,
16,
22,
23,
24,
25,
26,
31... | auspar-avanafil-161027.docx | task-634-81 | 44 | [
[
428,
128,
493,
144
],
[
496,
128,
559,
144
],
[
563,
128,
573,
144
],
[
577,
128,
592,
144
],
[
596,
128,
613,
144
],
[
428,
142,
499,
158
],
[
503,
142,
529,
158
],
[
53... | [
[
428,
128,
493,
144
],
[
496,
128,
559,
144
],
[
563,
128,
573,
144
],
[
577,
128,
592,
144
],
[
596,
128,
613,
144
],
[
428,
142,
499,
158
],
[
503,
142,
529,
158
],
[
53... |
Clinical Experience in Granulomatosis with polyangiitis (Wegener’s) (GPA) and Microscopic polyangiitis (MPA) In the RAVE 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see CLINICAL TRIALS). The ADRs listed in 21 were all adverse events which occurred at an incidence of... | Clinical Experience in Granulomatosis with polyangiitis (Wegener’s) (GPA) and Microscopic polyangiitis (MPA) In the RAVE 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see CLINICAL TRIALS). The ADRs listed in 21 were all adverse events which occurred at an incidence of... | 0.766861 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
50,
48,
49,
51,
52,
53,
54... | auspar-rituximab-180823-pi.docx | task-634-816 | 48 | [
[
120,
101,
188,
121
],
[
241,
101,
337,
121
],
[
342,
101,
359,
121
],
[
364,
101,
502,
121
],
[
507,
101,
545,
121
],
[
550,
101,
650,
121
],
[
655,
101,
760,
121
],
[
76... | [
[
120,
101,
188,
121
],
[
241,
101,
337,
121
],
[
342,
101,
359,
121
],
[
364,
101,
502,
121
],
[
507,
101,
545,
121
],
[
550,
101,
650,
121
],
[
655,
101,
760,
121
],
[
76... |
n (%) n (%) n (%) n HR HR (%) (95% (95% CI) CI) All Strata 5114 5115 10229 5113 (N) CV 313 313 626 (6.1) 376 0.020 0.85 0.84 0.008 Dth/MI/St (6.1) (6.1) (7.4) (0.73, (0.74, 0.98) 0.96) ( Dth/MI/St 320 321 641 (6.3) 386 0.016 0.84 0.84 0.006 (6.3) (6.3) (7.5) (0.73, (0.74, 0.98) 0.95) | n (%) n (%) n (%) n (%) HR (95% CI) HR (95% CI) All Strata (N) 5114 5115 10229 5113 CV Dth/MI/St 313 (6.1) 313 (6.1) 626 (6.1) 376 (7.4) 0.020 0.85 (0.73, 0.98) 0.84 (0.74, 0.96) 0.008 Dth/MI/St 320 (6.3) 321 (6.3) 641 (6.3) 386 (7.5) 0.016 0.84 (0.73, 0.98) 0.84 (0.74, 0.95) 0.006 ( | 0.278461 | [
0,
1,
2,
3,
4,
5,
6,
9,
7,
10,
12,
8,
11,
13,
14,
15,
20,
16,
17,
18,
19,
21,
31,
22,
32,
23,
33,
24,
25,
26,
34,
27,
28,
35,
37,
29,
36,
38,
30,
40,
41,
50,
42,
51,
43,
44,
45,
52,
46,
47,
53,
55,
48,
54,
56... | auspar-rivaroxaban-131111.docx | task-634-822 | 54 | [
[
224,
211,
234,
229
],
[
238,
211,
268,
229
],
[
291,
211,
301,
229
],
[
305,
211,
336,
229
],
[
367,
211,
377,
229
],
[
381,
211,
411,
229
],
[
480,
211,
490,
229
],
[
62... | [
[
224,
211,
234,
229
],
[
238,
211,
268,
229
],
[
291,
211,
301,
229
],
[
305,
211,
336,
229
],
[
367,
211,
377,
229
],
[
381,
211,
411,
229
],
[
480,
211,
490,
229
],
[
48... |
#131 PK, PD, safety, R - 5, 10, 25, 50, sd 23 Healthy tolerability, 100, 200 mg Phase I (up to 4) food effect, R - capsules (5, 25 mg); tablets 25 mg #132 PK, PD, safety, R- 15, 25, 50 mg md 71 Healthy tolerability bd; 50, 100 mg qd Phase I (10 days R capsules (5, – 25 mg) Placebo #134 Mass-balance R oral solution, sd ... | #131 Phase I PK, PD, safety, tolerability, food effect, R - 5, 10, 25, 50, 100, 200 mg R - capsules (5, 25 mg); tablets 25 mg sd (up to 4) 23 Healthy #132 Phase I PK, PD, safety, tolerability R- 15, 25, 50 mg bd; 50, 100 mg qd R – capsules (5, 25 mg) Placebo md (10 days 71 Healthy #134 Phase I Mass-balance and metaboli... | 0.449323 | [
0,
17,
18,
1,
2,
3,
13,
22,
23,
4,
5,
6,
7,
8,
9,
14,
15,
16,
24,
25,
26,
27,
28,
29,
30,
31,
32,
10,
19,
20,
21,
11,
12,
33,
51,
52,
34,
35,
36,
45,
37,
38,
39,
40,
41,
46,
47,
48,
49,
50,
55,
58,
56,
57,
59... | auspar-ruxolitinib-140121.docx | task-634-828 | 28 | [
[
142,
128,
184,
146
],
[
250,
128,
275,
146
],
[
279,
128,
306,
146
],
[
310,
128,
361,
146
],
[
380,
128,
392,
146
],
[
396,
128,
402,
146
],
[
406,
128,
420,
146
],
[
42... | [
[
142,
128,
184,
146
],
[
142,
151,
189,
169
],
[
193,
151,
199,
169
],
[
250,
128,
275,
146
],
[
279,
128,
306,
146
],
[
310,
128,
361,
146
],
[
250,
144,
341,
161
],
[
25... |
PGI2 Prostacyclin P-gp P-glycoprotein PI phototoxic index PK Pharmacokinetics PND day PO per os (oral (gavage)) PopPK/PD population pharmacokinetic(s)/pharmacodynamic(s) PPS Per-protocol set PR Pulse rate P-selectin platelet-selectin PT prothrombin time PT AUC0-144h area under the PT versus time curve to 144 h post dos... | PGI2 Prostacyclin P-gp P-glycoprotein PI phototoxic index PK Pharmacokinetics PND day PO per os (oral (gavage)) PopPK/PD population pharmacokinetic(s)/pharmacodynamic(s) PPS Per-protocol set PR Pulse rate P-selectin platelet-selectin PT prothrombin time PT AUC0-144h area under the PT versus time curve to 144 h post dos... | 0.960445 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-selexipag-161108.docx | task-634-849 | 9 | [
[
157,
97,
195,
115
],
[
368,
97,
465,
115
],
[
157,
128,
193,
146
],
[
368,
128,
484,
146
],
[
157,
159,
173,
177
],
[
368,
159,
453,
177
],
[
457,
159,
500,
177
],
[
157,... | [
[
157,
97,
195,
115
],
[
368,
97,
465,
115
],
[
157,
128,
193,
146
],
[
368,
128,
484,
146
],
[
157,
159,
173,
177
],
[
368,
159,
453,
177
],
[
457,
159,
500,
177
],
[
157,... |
in the proposed Australian PI and CMI have also been included. The pharmacovigilance plan for Australia does not differ from the actions described in the EU-RMP. Section 2.3 of the ASA includes a showing the safety concerns that will be addressed by all ongoing and planned studies as well as the date of submission of t... | in the proposed Australian PI and CMI have also been included. The pharmacovigilance plan for Australia does not differ from the actions described in the EU-RMP. Section 2.3 of the ASA includes a showing the safety concerns that will be addressed by all ongoing and planned studies as well as the date of submission of t... | 0.872385 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-simoctocog-alfa-rhu-160607.docx | task-634-864 | 50 | [
[
460,
90,
475,
108
],
[
479,
90,
505,
108
],
[
509,
90,
584,
108
],
[
460,
106,
542,
124
],
[
546,
106,
562,
124
],
[
567,
106,
596,
124
],
[
460,
121,
491,
139
],
[
495,
... | [
[
460,
90,
475,
108
],
[
479,
90,
505,
108
],
[
509,
90,
584,
108
],
[
460,
106,
542,
124
],
[
546,
106,
562,
124
],
[
567,
106,
596,
124
],
[
460,
121,
491,
139
],
[
495,
... |
Contents of the clinical dossier of the clinical dossier The clinical dossier documented a development program of pharmacology, efficacy and safety studies relating to the proposed extension of indications. The submission contained the following clinical information: Ten clinical pharmacology studies, including six tha... | Contents of the clinical dossier of the clinical dossier The clinical dossier documented a development program of pharmacology, efficacy and safety studies relating to the proposed extension of indications. The submission contained the following clinical information: Ten clinical pharmacology studies, including six tha... | 0.971523 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | auspar-tadalafil-130722-cer.docx | task-634-891 | 10 | [
[
168,
88,
284,
114
],
[
292,
88,
317,
114
],
[
325,
88,
365,
114
],
[
372,
88,
463,
114
],
[
471,
88,
566,
114
],
[
260,
135,
277,
153
],
[
282,
135,
310,
153
],
[
315,
... | [
[
168,
88,
284,
114
],
[
292,
88,
317,
114
],
[
325,
88,
365,
114
],
[
372,
88,
463,
114
],
[
471,
88,
566,
114
],
[
260,
135,
277,
153
],
[
282,
135,
310,
153
],
[
315,
... |
Interaction with CYP3A4 – Inhibitors Interaction with CYP3A4 – Inducers Interaction with – vasopressin receptor agonists Pharmacodynamic – – Interaction tolvaptan and combined administration of diuretics leading to dehydration and renal dysfunction Liver injury in ADPKD patients Anaphylaxis – Important urinary retentio... | Interaction with CYP3A4 Inhibitors – Interaction with CYP3A4 Inducers – Interaction with vasopressin receptor agonists – Pharmacodynamic Interaction tolvaptan and combined administration of diuretics leading to dehydration and renal dysfunction – – Liver injury in ADPKD patients Anaphylaxis – Important potential urinar... | 0.647761 | [
0,
1,
2,
4,
3,
5,
6,
7,
9,
8,
10,
11,
13,
14,
15,
12,
16,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
17,
18,
32,
33,
34,
35,
36,
37,
38,
39,
44,
40,
41,
42,
45,
46,
47,
48,
43,
49,
50,
51,
52,
53,
54... | auspar-tolvaptan-180209.docx | task-634-952 | 35 | [
[
249,
98,
329,
114
],
[
332,
98,
365,
114
],
[
369,
98,
426,
114
],
[
761,
99,
769,
113
],
[
249,
112,
320,
128
],
[
249,
142,
329,
158
],
[
332,
142,
365,
158
],
[
369,
... | [
[
249,
98,
329,
114
],
[
332,
98,
365,
114
],
[
369,
98,
426,
114
],
[
249,
112,
320,
128
],
[
761,
99,
769,
113
],
[
249,
142,
329,
158
],
[
332,
142,
365,
158
],
[
369,
... |
product are ~5-times higher than those for EllaOne based on AUC (human AUC0-24 h after a single 30 mg dose, 0.556 and 6 times higher based on body surface area. μg∙h/mL) Table 2. Estimated relative exposure to ulipristal acetate in selected toxicity studies. Species Study Dose AUC0–24 Exposure duration h mg/kg/day mg/m... | product are ~5-times higher than those for EllaOne based on AUC (human AUC0-24 h after a single 30 mg dose, 0.556 μg∙h/mL) and 6 times higher based on body surface area. Table 2. Estimated relative exposure to ulipristal acetate in selected toxicity studies. Species Study duration Dose AUC0–24 h Exposure mg/kg/day mg/m... | 0.622742 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
30,
21,
22,
23,
24,
25,
26,
27,
28,
29,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
48,
45,
46,
49,
47,
50,
51,
52,
53,
54... | auspar-ulipristal-acetate-161019.docx | task-634-975 | 13 | [
[
142,
89,
205,
107
],
[
209,
89,
235,
107
],
[
239,
89,
312,
107
],
[
316,
89,
367,
107
],
[
371,
89,
407,
107
],
[
411,
89,
454,
107
],
[
458,
89,
481,
107
],
[
485,
... | [
[
142,
89,
205,
107
],
[
209,
89,
235,
107
],
[
239,
89,
312,
107
],
[
316,
89,
367,
107
],
[
371,
89,
407,
107
],
[
411,
89,
454,
107
],
[
458,
89,
481,
107
],
[
485,
... |
For the important identified moderate risk: and the to severe hepatic ‘Hepatotoxicity’ missing information: impairment are with hepatic not currently ‘Patients impairment’, the Dosage and available, and Administration section of the therefore, agrees Australian PI states: that ceritinib ‘Caution should be used in patie... | For the important identified risk: ‘Hepatotoxicity’ and the missing information: ‘Patients with hepatic impairment’, the Dosage and Administration section of the Australian PI states: ‘Caution should be used in patients with severe renal impairment as there is no experience with ZYKADIA in this population (see Pharmaco... | 0.444219 | [
0,
1,
2,
3,
5,
11,
6,
7,
12,
13,
20,
16,
17,
21,
22,
23,
24,
27,
28,
29,
30,
33,
34,
35,
38,
39,
40,
41,
42,
43,
47,
48,
49,
50,
53,
54,
55,
56,
57,
58,
61,
62,
63,
64,
68,
69,
71,
72,
75,
76,
77,
78,
81,
82,
... | auspar-zykadia-270218.docx | task-635-15 | 42 | [
[
178,
90,
204,
108
],
[
208,
90,
231,
108
],
[
236,
90,
307,
108
],
[
312,
90,
383,
108
],
[
510,
90,
584,
108
],
[
178,
105,
211,
123
],
[
342,
105,
369,
123
],
[
374,
... | [
[
178,
90,
204,
108
],
[
208,
90,
231,
108
],
[
236,
90,
307,
108
],
[
312,
90,
383,
108
],
[
178,
105,
211,
123
],
[
216,
108,
338,
122
],
[
342,
105,
369,
123
],
[
374,
... |
High-quality, low-maintenance explosion-protected variable luminaire available with sealed connection cable or connection chamber. Using a corrosion-resistant light metal enclosure and a high IP level of protection the luminaire is also suitable for extreme ambient conditions. Enclosure material : Sheet steel, powder-c... | High-quality, low-maintenance explosion-protected variable luminaire available with sealed connection cable or connection chamber. Using a corrosion-resistant light metal enclosure and a high IP level of protection the luminaire is also suitable for extreme ambient conditions. Enclosure material : Sheet steel, powder-c... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Ausschreibungstext_6521_4_EN.docx | task-635-284 | 11 | [
[
119,
81,
241,
107
],
[
247,
81,
414,
107
],
[
420,
81,
612,
107
],
[
618,
81,
695,
107
],
[
701,
81,
791,
107
],
[
119,
103,
205,
129
],
[
212,
103,
251,
129
],
[
257,
... | [
[
119,
81,
241,
107
],
[
247,
81,
414,
107
],
[
420,
81,
612,
107
],
[
618,
81,
695,
107
],
[
701,
81,
791,
107
],
[
119,
103,
205,
129
],
[
212,
103,
251,
129
],
[
257,
... |
High quality low maintenance explosion-protected Linear Luminaire for Fluorescent plastic-made with lamp base G13. With a central lock for easy opening and closing of the luminaire. Including through wiring with 5 cores for electrical connection on both ends. Enclosure material : Polyester resin glass fibre-reinforced ... | High quality low maintenance explosion-protected Linear Luminaire for Fluorescent plastic-made with lamp base G13. With a central lock for easy opening and closing of the luminaire. Including through wiring with 5 cores for electrical connection on both ends. Enclosure material : Polyester resin glass fibre-reinforced ... | 0.980002 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Ausschreibungstext_EXLUX_6001_EN.docx | task-635-333 | 28 | [
[
119,
81,
164,
107
],
[
170,
81,
234,
107
],
[
240,
81,
273,
107
],
[
279,
81,
405,
107
],
[
417,
81,
610,
107
],
[
622,
81,
683,
107
],
[
689,
81,
786,
107
],
[
792,
... | [
[
119,
81,
164,
107
],
[
170,
81,
234,
107
],
[
240,
81,
273,
107
],
[
279,
81,
405,
107
],
[
417,
81,
610,
107
],
[
622,
81,
683,
107
],
[
689,
81,
786,
107
],
[
792,
... |
lower for Western region grain producing farms, partly because of the larger average size of grain enterprises in this region. At 30 June 2013, the average equity ratio for Western region grain producing farms was estimated to have been 73 per cent and the average for both the Northern region and Southern region was 84... | lower for Western region grain producing farms, partly because of the larger average size of grain enterprises in this region. At 30 June 2013, the average equity ratio for Western region grain producing farms was estimated to have been 73 per cent and the average for both the Northern region and Southern region was 84... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | AustFinPerfGrnProdFrm2014_v.1.0.0.docx | task-635-737 | 7 | [
[
119,
73,
164,
91
],
[
168,
73,
191,
91
],
[
195,
73,
263,
91
],
[
267,
73,
318,
91
],
[
322,
73,
363,
91
],
[
367,
73,
448,
91
],
[
452,
73,
501,
91
],
[
505,
73,
... | [
[
119,
73,
164,
91
],
[
168,
73,
191,
91
],
[
195,
73,
263,
91
],
[
267,
73,
318,
91
],
[
322,
73,
363,
91
],
[
367,
73,
448,
91
],
[
452,
73,
501,
91
],
[
505,
73,
... |
Furniture, Floor Covering and 373 Other Goods Wholesaling Furniture and Floor Covering 3731 5.5.1 Wholesaling Jewellery and Watch 3732 5.5.1 Wholesaling Kitchen and Diningware 3733 5.5.1 Wholesaling Toy and Sporting Goods 3734 5.5.1 Wholesaling Book and Magazine 3735 5.5.1 Wholesaling Paper Product Wholesaling 3736 5.5... | Furniture, Floor Covering and Other Goods Wholesaling 373 Furniture and Floor Covering Wholesaling 3731 5.5.1 Jewellery and Watch Wholesaling 3732 5.5.1 Kitchen and Diningware Wholesaling 3733 5.5.1 Toy and Sporting Goods Wholesaling 3734 5.5.1 Book and Magazine Wholesaling 3735 5.5.1 Paper Product Wholesaling 3736 5.5... | 0.636097 | [
0,
1,
2,
3,
5,
6,
7,
4,
8,
9,
10,
11,
14,
12,
13,
15,
16,
17,
20,
18,
19,
21,
22,
23,
26,
24,
25,
27,
28,
29,
30,
33,
31,
32,
34,
35,
36,
39,
37,
38,
40,
41,
42,
43,
44,
45,
46,
47,
50,
48,
49,
51,
54,
55,
56... | AustLandUseMgtClassfnVersion8_v1.0.0.docx | task-635-799 | 81 | [
[
293,
130,
368,
145
],
[
373,
130,
411,
145
],
[
416,
130,
484,
145
],
[
489,
130,
517,
145
],
[
543,
130,
572,
145
],
[
293,
143,
336,
158
],
[
342,
143,
389,
158
],
[
39... | [
[
293,
130,
368,
145
],
[
373,
130,
411,
145
],
[
416,
130,
484,
145
],
[
489,
130,
517,
145
],
[
293,
143,
336,
158
],
[
342,
143,
389,
158
],
[
394,
143,
485,
158
],
[
54... |
Other Transport Support 5299 5.5.1 Services n.e.c. Warehousing and Warehousing and Storage 530 Storage Services - Services 53 Grain Storage Services 5301 5.5.1 Other Warehousing and 5309 5.5.1 Storage Services J Information and Telecommunications Publishing (except Newspaper, Periodical, Book 541 Internet and Music and... | Other Transport Support Services n.e.c. 5299 5.5.1 Warehousing and Storage Services - 53 Warehousing and Storage Services 530 Grain Storage Services 5301 5.5.1 Other Warehousing and Storage Services 5309 5.5.1 J Information and Telecommunications Publishing (except Internet and Music Publishing) - 54 Newspaper, Periodi... | 0.572643 | [
0,
1,
2,
5,
6,
3,
4,
7,
8,
13,
14,
15,
17,
9,
10,
11,
16,
12,
18,
19,
20,
21,
22,
23,
24,
25,
28,
29,
26,
27,
30,
31,
32,
33,
34,
35,
40,
41,
42,
46,
47,
48,
36,
37,
38,
43,
44,
45,
39,
49,
50,
51,
52,
53,
54... | AustLandUseMgtClassfnVersion8_v1.0.0.docx | task-635-799 | 85 | [
[
293,
130,
336,
145
],
[
342,
130,
415,
145
],
[
420,
130,
480,
145
],
[
543,
130,
582,
145
],
[
805,
130,
845,
145
],
[
293,
143,
357,
158
],
[
362,
143,
405,
158
],
[
13... | [
[
293,
130,
336,
145
],
[
342,
130,
415,
145
],
[
420,
130,
480,
145
],
[
293,
143,
357,
158
],
[
362,
143,
405,
158
],
[
543,
130,
582,
145
],
[
805,
130,
845,
145
],
[
13... |
# Survey Target Response Region Country respondents population rate Indonesia 760 1996 38% Mongolia 39 74 53% East Asia China 11 102 11% Timor-Leste 8 21 38% Fiji 6 25 24% Solomon Islands 5 23 22% Pacific Island Vanuatu 5 25 20% Countries Tuvalu 4 15 27% French Polynesia 2 5 40% Pakistan 105 249 42% & West Asia Banglad... | Region Country # Survey respondents Target population Response rate East Asia Indonesia 760 1996 38% Mongolia 39 74 53% China 11 102 11% Timor-Leste 8 21 38% Pacific Island Countries Fiji 6 25 24% Solomon Islands 5 23 22% Vanuatu 5 25 20% Tuvalu 4 15 27% French Polynesia 2 5 40% & West Asia Pakistan 105 249 42% Banglad... | 0.69995 | [
4,
5,
0,
1,
6,
2,
7,
3,
8,
17,
18,
9,
10,
11,
12,
13,
14,
15,
16,
19,
20,
21,
22,
23,
24,
25,
26,
36,
37,
42,
27,
28,
29,
30,
31,
32,
33,
34,
35,
38,
39,
40,
41,
43,
44,
45,
46,
47,
48,
49,
50,
51,
56,
57,
58... | australia-awards-global-tracer-facility-tracer-survey-alumni-of-2006-2010.docx | task-635-854 | 13 | [
[
605,
189,
614,
205
],
[
619,
189,
675,
205
],
[
733,
189,
784,
205
],
[
832,
189,
912,
205
],
[
175,
196,
232,
212
],
[
351,
196,
415,
212
],
[
589,
202,
690,
219
],
[
71... | [
[
175,
196,
232,
212
],
[
351,
196,
415,
212
],
[
605,
189,
614,
205
],
[
619,
189,
675,
205
],
[
589,
202,
690,
219
],
[
733,
189,
784,
205
],
[
716,
202,
802,
219
],
[
83... |
Yes 186 35% Have you received any No 340 65% other scholarships? Don't know 1 0% Employed full-time 479 91% Employed part-time 7 1% What is your current Not employed 4 1% employment status? Retired 3 1% Other (specify) 34 6% | Have you received any other scholarships? Yes 186 35% No 340 65% Don't know 1 0% What is your current employment status? Employed full-time 479 91% Employed part-time 7 1% Not employed 4 1% Retired 3 1% Other (specify) 34 6% | 0.614687 | [
3,
4,
5,
6,
10,
11,
0,
1,
2,
7,
8,
9,
12,
13,
14,
15,
24,
25,
26,
27,
32,
33,
16,
17,
18,
19,
20,
21,
22,
23,
28,
29,
30,
31,
34,
35,
36,
37,
38,
39,
40
] | australia-awards-global-tracer-facility-tracer-survey-alumni-of-2006-2010.docx | task-635-854 | 42 | [
[
389,
223,
418,
240
],
[
670,
223,
698,
240
],
[
784,
223,
817,
240
],
[
175,
235,
215,
252
],
[
220,
235,
250,
252
],
[
255,
235,
323,
252
],
[
327,
235,
356,
252
],
[
38... | [
[
175,
235,
215,
252
],
[
220,
235,
250,
252
],
[
255,
235,
323,
252
],
[
327,
235,
356,
252
],
[
175,
249,
217,
265
],
[
222,
249,
336,
265
],
[
389,
223,
418,
240
],
[
67... |
AAPNG Facility For completion by tasked through this October 2017 Recommendation 2 Agree management response to review That the current level of the current level of stipend paid to awardees stipends and other be reviewed to ensure entitlements for consistency across discussion with courses and Tertiary AHC. Education ... | Recommendation 2 That the current level of stipend paid to awardees be reviewed to ensure consistency across courses and Tertiary Education Providers (TEPs) and comparability with the experience and expectations of non-In country Scholarship (ICS) holders. Agree AAPNG Facility tasked through this management response to... | 0.478643 | [
10,
11,
17,
18,
19,
20,
21,
26,
27,
28,
29,
33,
34,
35,
36,
39,
40,
43,
44,
45,
47,
48,
49,
50,
51,
52,
53,
54,
55,
56,
57,
58,
59,
60,
61,
62,
12,
0,
1,
5,
6,
7,
13,
14,
15,
16,
22,
23,
24,
25,
30,
31,
32,
37,... | australia-awards-in-country-scholarships-review-mgt-resp.docx | task-635-857 | 1 | [
[
616,
93,
670,
111
],
[
674,
93,
727,
111
],
[
786,
93,
810,
111
],
[
815,
93,
900,
111
],
[
904,
93,
922,
111
],
[
616,
109,
665,
127
],
[
670,
109,
730,
127
],
[
734,
... | [
[
104,
119,
249,
138
],
[
254,
119,
264,
138
],
[
104,
143,
138,
161
],
[
142,
143,
167,
161
],
[
171,
143,
226,
161
],
[
231,
143,
266,
161
],
[
270,
143,
285,
161
],
[
10... |
AusAID and SetNeg stakeholders will be invited to participate in these workshops, in order to develop common understandings of the data. Jointly making sense of program data, and discussing its implications for program management and implementation, will enhance data analysis and also build a deeper collective engageme... | AusAID and SetNeg stakeholders will be invited to participate in these workshops, in order to develop common understandings of the data. Jointly making sense of program data, and discussing its implications for program management and implementation, will enhance data analysis and also build a deeper collective engageme... | 0.764144 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | australia-awards-indonesia-investment-design-doc.docx | task-635-858 | 48 | [
[
151,
82,
218,
102
],
[
225,
82,
254,
102
],
[
262,
82,
318,
102
],
[
326,
82,
423,
102
],
[
431,
82,
458,
102
],
[
466,
82,
484,
102
],
[
492,
82,
545,
102
],
[
553,
... | [
[
151,
82,
218,
102
],
[
225,
82,
254,
102
],
[
262,
82,
318,
102
],
[
326,
82,
423,
102
],
[
431,
82,
458,
102
],
[
466,
82,
484,
102
],
[
492,
82,
545,
102
],
[
553,
... |
certificate/Diploma training in quality/productivity etc (as below Vietnam with higher selected workplaces; and extent in Milestones). learning of a quality they change in women and PWD who would not otherwise use new training/knowledge in have). selected workplaces. Actual: Intermediate outcome or % increase annually ... | certificate/Diploma training in selected workplaces; and extent change in women and PWD who use new training/knowledge in selected workplaces. quality/productivity etc (as below in Milestones). Vietnam with higher learning of a quality they would not otherwise have). Actual: Intermediate outcome or output - Refer Outco... | 0.64361 | [
0,
1,
2,
10,
11,
12,
13,
21,
22,
23,
24,
25,
26,
30,
31,
32,
33,
35,
36,
3,
4,
5,
6,
14,
15,
7,
8,
9,
16,
17,
18,
19,
20,
27,
28,
29,
34,
37,
38,
39,
40,
58,
59,
60,
61,
62,
72,
41,
42,
43,
44,
45,
63,
64,
65... | australia-vietnam-hrd-program-design-annex1.docx | task-635-907 | 39 | [
[
178,
85,
262,
106
],
[
264,
85,
298,
106
],
[
300,
85,
308,
106
],
[
338,
85,
424,
106
],
[
427,
85,
440,
106
],
[
443,
85,
455,
106
],
[
458,
85,
484,
106
],
[
508,
... | [
[
178,
85,
262,
106
],
[
264,
85,
298,
106
],
[
300,
85,
308,
106
],
[
178,
104,
214,
125
],
[
216,
104,
268,
125
],
[
271,
104,
287,
125
],
[
289,
104,
317,
125
],
[
178,
... |
Intermediate outcome or [Abridged refer above] - (i) As above 2015 Target: TBA TBA TBA TBA TBA output - Refer Outcome 2 Number new staff trained; (ii) in sheet Number activities to develop/deliver TA/Training completed satisfactorily at sectoral level; and (iii) at as organisation level etc Actual: Outcome 3: End-of-st... | Intermediate outcome or output - Refer Outcome 2 sheet [Abridged refer above] - (i) Number new staff trained; (ii) Number activities to develop/deliver TA/Training completed satisfactorily at sectoral level; and (iii) at organisation level As above 2015 Target: TBA in as etc TBA TBA TBA TBA Actual: Outcome 3: End-of-st... | 0.582716 | [
0,
1,
2,
17,
18,
19,
20,
21,
28,
3,
4,
5,
6,
7,
22,
23,
24,
25,
26,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
43,
44,
8,
9,
10,
11,
12,
27,
42,
45,
13,
14,
15,
16,
46,
47,
48,
49,
50,
69,
70,
71,
72... | australia-vietnam-hrd-program-design-annex1.docx | task-635-907 | 40 | [
[
50,
85,
108,
106
],
[
111,
85,
150,
106
],
[
153,
85,
162,
106
],
[
178,
85,
221,
106
],
[
223,
85,
244,
106
],
[
247,
85,
276,
106
],
[
279,
85,
282,
106
],
[
285,
8... | [
[
50,
85,
108,
106
],
[
111,
85,
150,
106
],
[
153,
85,
162,
106
],
[
50,
104,
80,
125
],
[
83,
104,
86,
125
],
[
88,
104,
112,
125
],
[
115,
104,
156,
125
],
[
158,
10... |
prices of lower-carbon fuels compared with other fossil fuels as gas prices are projected to rise significantly compared with black and brown coal prices AEMO NEFR (2013). Gas prices are projected to increase by approximately 42 per cent until 2020 whereas coal prices are projected to stay constant, as shown in Figure ... | prices of lower-carbon fuels compared with other fossil fuels as gas prices are projected to rise significantly compared with black and brown coal prices AEMO NEFR (2013). Gas prices are projected to increase by approximately 42 per cent until 2020 whereas coal prices are projected to stay constant, as shown in Figure ... | 1 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Australiaelectricityandemissionsfinalreport.docx | task-635-914 | 53 | [
[
95,
118,
139,
135
],
[
143,
118,
159,
135
],
[
163,
118,
262,
135
],
[
266,
118,
302,
135
],
[
307,
118,
380,
135
],
[
384,
118,
417,
135
],
[
422,
118,
460,
135
],
[
464... | [
[
95,
118,
139,
135
],
[
143,
118,
159,
135
],
[
163,
118,
262,
135
],
[
266,
118,
302,
135
],
[
307,
118,
380,
135
],
[
384,
118,
417,
135
],
[
422,
118,
460,
135
],
[
464... |
of ensuring that ADF mental health screening, awareness, early intervention and treatment programs are available to all ADF members regardless of their deployment status. A primary aim of mental health screening is to facilitate early intervention for treatment of mental health problems and mental illness. It does not ... | of ensuring that ADF mental health screening, awareness, early intervention and treatment programs are available to all ADF members regardless of their deployment status. A primary aim of mental health screening is to facilitate early intervention for treatment of mental health problems and mental illness. It does not ... | 0.99038 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Australian%20Government%20Response%20Senate%20Inquiry%20Mental%20Health.docx | task-635-939 | 4 | [
[
119,
64,
135,
83
],
[
140,
64,
210,
83
],
[
215,
64,
245,
83
],
[
250,
64,
290,
83
],
[
295,
64,
350,
83
],
[
355,
64,
404,
83
],
[
409,
64,
492,
83
],
[
497,
64,
... | [
[
119,
64,
135,
83
],
[
140,
64,
210,
83
],
[
215,
64,
245,
83
],
[
250,
64,
290,
83
],
[
295,
64,
350,
83
],
[
355,
64,
404,
83
],
[
409,
64,
492,
83
],
[
497,
64,
... |
Table 3. Trachoma control delivery by region, South Australia 2015 Number of APY Lands Eyre and Western Far Total communities At risk* (A) 1* 4 6 11 Requiring screening for 1 4 6 11 trachoma (B) Screened for 1 4 6 11 trachoma (C) Requiring 0 0 0 0 treatment only (D) Treated (E) 0 0 0 0 † Screened and/or treated for 1 4... | Table 3. Trachoma control delivery by region, South Australia 2015 Number of communities APY Lands Eyre and Western Far Total At risk* (A) 1* 4 6 11 Requiring screening for trachoma (B) 1 4 6 11 Screened for trachoma (C) 1 4 6 11 Requiring treatment only (D) 0 0 0 0 Treated † (E) 0 0 0 0 Screened and/or treated for tra... | 0.751608 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
19,
12,
13,
14,
15,
16,
17,
18,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
34,
35,
30,
31,
32,
33,
36,
37,
42,
43,
38,
39,
40,
41,
44,
49,
50,
51,
45,
46,
47,
48,
52,
58,
53... | Australian-Trachoma-Surveillance-Report-2015.docx | task-636-106 | 34 | [
[
42,
84,
73,
110
],
[
76,
84,
86,
110
],
[
92,
84,
149,
110
],
[
151,
84,
192,
110
],
[
195,
84,
240,
110
],
[
243,
84,
257,
110
],
[
260,
84,
298,
110
],
[
301,
84,
... | [
[
42,
84,
73,
110
],
[
76,
84,
86,
110
],
[
92,
84,
149,
110
],
[
151,
84,
192,
110
],
[
195,
84,
240,
110
],
[
243,
84,
257,
110
],
[
260,
84,
298,
110
],
[
301,
84,
... |
& 2 1 2 1201, 12 15-17 BARTON ACT 2600 275 MELBOURNE VIC 3000 SYDNEY NSW 2060 T: 02 6273 1466 T: 03 9614 1111 F: 02 6273 1477 T: 02 9922 3955 F: 03 9614 1166 E: F: 02 9929 9743 E: W: E: W: W: 1, 16 10 YARRALUMLA ACT 2600 QANTAS 136 QANTAS MELBOURNE VIC 3000 T: 02 6202 8888 QCD1, 203 F: 02 6202 8877 MASCOT NSW 2020 T: 1... | & 2 2 BARTON ACT 2600 T: 02 6273 1466 F: 02 6273 1477 E: W: 1201, 12 275 SYDNEY NSW 2060 T: 02 9922 3955 F: 02 9929 9743 E: W: 1 15-17 MELBOURNE VIC 3000 T: 03 9614 1111 F: 03 9614 1166 E: W: QANTAS QANTAS QCD1, 203 MASCOT NSW 2020 T: 02 9691 3636 F: 02 9691 2065 10 136 MELBOURNE VIC 3000 T: 1300 368 041 F: 03 8660 339... | 0.528682 | [
0,
1,
3,
7,
8,
9,
17,
18,
19,
20,
25,
26,
27,
28,
37,
43,
4,
5,
10,
14,
15,
16,
29,
30,
31,
32,
38,
39,
40,
41,
44,
46,
2,
6,
11,
12,
13,
21,
22,
23,
24,
33,
34,
35,
36,
42,
45,
53,
55,
63,
64,
69,
70,
71,
82... | australianchamberofcommerceandindustry.docx | task-636-131 | 73 | [
[
239,
108,
250,
122
],
[
154,
121,
161,
135
],
[
690,
121,
698,
135
],
[
114,
134,
122,
148
],
[
462,
134,
496,
148
],
[
539,
134,
554,
148
],
[
651,
134,
686,
148
],
[
11... | [
[
239,
108,
250,
122
],
[
154,
121,
161,
135
],
[
114,
134,
122,
148
],
[
114,
147,
167,
161
],
[
170,
147,
194,
161
],
[
198,
147,
228,
161
],
[
114,
173,
126,
187
],
[
12... |
Dundas (S) 40 212205 Pingelly (S) 190 212205 East Fremantle Plantagenet (T) 780 212205 (S) 720 212205 Port Hedland East Pilbara (S) 260 212205 (T) 700 212205 Quairading Esperance (S) 1700 212205 (S) 130 212205 Ravensthorpe Exmouth (S) 200 212205 (S) 320 212205 Rockingham Fremantle (C) 4100 212205 (C) 6270 212205 Roebou... | Dundas (S) 40 212205 Pingelly (S) 190 212205 East Fremantle (T) 780 212205 Plantagenet (S) 720 212205 East Pilbara (S) 260 212205 Port Hedland (T) 700 212205 Esperance (S) 1700 212205 Quairading (S) 130 212205 Exmouth (S) 200 212205 Ravensthorpe (S) 320 212205 Fremantle (C) 4100 212205 Rockingham (C) 6270 212205 (C) 31... | 0.804815 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
11,
12,
13,
10,
14,
15,
16,
19,
20,
21,
22,
23,
17,
18,
24,
25,
26,
28,
29,
30,
31,
27,
32,
33,
34,
36,
37,
38,
39,
35,
40,
41,
42,
44,
45,
46,
47,
43,
48,
49,
50,
52,
53,
54,
51... | AustralianSmallBusinessKeyStatisticsAndAnalysis.docx | task-636-147 | 69 | [
[
160,
84,
211,
101
],
[
215,
84,
233,
101
],
[
363,
84,
380,
101
],
[
442,
84,
493,
101
],
[
511,
84,
564,
101
],
[
568,
84,
586,
101
],
[
694,
84,
719,
101
],
[
781,
... | [
[
160,
84,
211,
101
],
[
215,
84,
233,
101
],
[
363,
84,
380,
101
],
[
442,
84,
493,
101
],
[
511,
84,
564,
101
],
[
568,
84,
586,
101
],
[
694,
84,
719,
101
],
[
781,
... |
AMMA maintains that accompanied with genuine attempts to reach protected industrial action agreement), it cannot of itself constitute bad faith. should only be available as The imposition of the restrictions suggested would a last resort after a move Australia even further away from our demonstrated attempt has interna... | AMMA maintains that protected industrial action should only be available as a last resort after a demonstrated attempt has been made to exhaust all bargaining options, including mediation. To resort to coercion via protected industrial action as a first means of attack should be deemed at odds accompanied with genuine ... | 0.74818 | [
0,
1,
2,
9,
10,
11,
20,
21,
22,
23,
24,
32,
33,
34,
35,
36,
44,
45,
46,
53,
54,
55,
56,
57,
66,
67,
68,
69,
70,
71,
72,
73,
74,
75,
76,
77,
86,
87,
88,
89,
90,
91,
101,
102,
103,
104,
105,
3,
4,
5,
6,
7,
8,
12,... | australian_council_of_trade_unions_supp.docx | task-636-171 | 36 | [
[
201,
714,
262,
732
],
[
267,
714,
353,
732
],
[
358,
714,
395,
732
],
[
475,
714,
575,
732
],
[
579,
714,
613,
732
],
[
617,
714,
677,
732
],
[
681,
714,
750,
732
],
[
75... | [
[
201,
714,
262,
732
],
[
267,
714,
353,
732
],
[
358,
714,
395,
732
],
[
201,
730,
292,
748
],
[
297,
730,
375,
748
],
[
380,
730,
438,
748
],
[
201,
746,
259,
764
],
[
26... |
Examples of Activities performed for, or at the compliance audits request of, or on the application of, a activity investigations particular individual or body, such as: outputs development and promulgation of and the issue of permits, licences and regulatory standards business registrations policy development processe... | Examples of activity outputs and business processes Activities performed for, or at the request of, or on the application of, a particular individual or body, such as: the issue of permits, licences and registrations inspections as part of issuing permits, licences and registrations the approval of deviations from comm... | 0.721777 | [
0,
1,
18,
26,
31,
40,
44,
2,
3,
4,
5,
6,
7,
10,
11,
12,
13,
14,
15,
16,
17,
20,
21,
22,
23,
24,
25,
32,
33,
34,
35,
36,
37,
41,
45,
46,
47,
48,
49,
53,
54,
55,
56,
61,
62,
63,
64,
65,
69,
70,
77,
78,
79,
80,
... | australian-government-cost-recovery-guidelines.docx | task-636-19 | 31 | [
[
92,
126,
167,
145
],
[
171,
126,
187,
145
],
[
204,
126,
280,
144
],
[
285,
126,
374,
144
],
[
379,
126,
407,
144
],
[
412,
126,
430,
144
],
[
435,
126,
451,
144
],
[
457... | [
[
92,
126,
167,
145
],
[
171,
126,
187,
145
],
[
92,
143,
149,
162
],
[
92,
160,
154,
178
],
[
92,
176,
122,
195
],
[
92,
193,
160,
212
],
[
92,
210,
170,
229
],
[
204,
... |
Intensive 0-17 years - 1, 1, 1, 1, 1, 1 12 High - 131A Admitted, Intensive extended, extended 1, 1, 1, 1, 1, 0-17 years, High HoNOS 1, 1, 1 complexity Moderate - 131B Admitted, Intensive extended, 0-17 years, Moderate HoNOS complexity Unknown - 131Z Admitted, Intensive extended, 0-17 years, Unknown HoNOS 18-64 years - ... | Intensive extended 0-17 years - 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 1 12 High - 131A Admitted, Intensive extended, 0-17 years, High HoNOS complexity Moderate - 131B Admitted, Intensive extended, 0-17 years, Moderate HoNOS complexity Unknown - 131Z Admitted, Intensive extended, 0-17 years, Unknown HoNOS 18-64 years - ... | 0.755606 | [
0,
17,
1,
2,
3,
4,
5,
6,
7,
8,
18,
19,
20,
21,
22,
27,
28,
29,
9,
10,
11,
12,
13,
14,
15,
16,
23,
24,
25,
26,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | australian_mental_health_care_classification_amhcc_v1.0_user_manual_2018.docx | task-636-210 | 24 | [
[
78,
236,
126,
259
],
[
154,
236,
178,
259
],
[
181,
236,
210,
259
],
[
252,
236,
256,
259
],
[
297,
236,
306,
259
],
[
310,
236,
320,
259
],
[
323,
236,
333,
259
],
[
336... | [
[
78,
236,
126,
259
],
[
78,
255,
127,
278
],
[
154,
236,
178,
259
],
[
181,
236,
210,
259
],
[
252,
236,
256,
259
],
[
297,
236,
306,
259
],
[
310,
236,
320,
259
],
[
323,... |
RDA RDA Element Data Recorded Reference 4: 2.3 of manifestation Dracula From title page 2.3.6 Variant title of manifestation 2.4.2 Statement of Bram Stoker From title responsibility page. Core 2.5 Edition statement No edition 2.8.2 of publication Melbourne 2.8.4 Name of publisher Brolga Publishing 2.8.6 Date of publica... | RDA Reference RDA Element Data Recorded 2.3 of manifestation Dracula From title page 2.3.6 Variant title of manifestation 2.4.2 Statement of responsibility Bram Stoker From title page. Core 2.5 Edition statement No edition 2.8.2 of publication Melbourne 2.8.4 Name of publisher Brolga Publishing 2.8.6 Date of publicatio... | 0.757763 | [
0,
5,
1,
2,
3,
4,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
26,
22,
23,
24,
25,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54,
5... | australian_train_the_trainer_-_module_14.docx | task-636-236 | 8 | [
[
196,
128,
238,
151
],
[
316,
128,
359,
151
],
[
363,
128,
444,
151
],
[
524,
128,
569,
151
],
[
574,
128,
668,
151
],
[
168,
148,
266,
170
],
[
117,
156,
132,
177
],
[
16... | [
[
196,
128,
238,
151
],
[
168,
148,
266,
170
],
[
316,
128,
359,
151
],
[
363,
128,
444,
151
],
[
524,
128,
569,
151
],
[
574,
128,
668,
151
],
[
168,
172,
191,
191
],
[
32... |
Exercise 17 cont. C: Corporate bodies 5. Use the template below to create an authority record for the Abyssinian Cat club of Australasia. Title page: Cover RDA RDA Notes MARC Data Recorded Reference Element field 046 $s 1966 11.2 110 Abyssinian Cat Club of Australasia 2# $a 11.3 370 Sydney, N.S.W. $e 11.9 371 PO Box 31... | Exercise 17 cont. C: Corporate bodies 5. Use the template below to create an authority record for the Abyssinian Cat club of Australasia. Title page: Cover RDA Reference RDA Element Notes MARC field Data Recorded 046 $s 1966 11.2 110 2# $a Abyssinian Cat Club of Australasia 11.3 370 $e Sydney, N.S.W. 11.9 371 $a PO Box... | 0.679233 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
32,
27,
33,
28,
29,
34,
30,
31,
35,
36,
37,
38,
39,
45,
46,
40,
41,
42,
43,
44,
47,
48,
51,
49,
50,
52,
53,
59... | australian_train_the_trainer_text_-_rda_train_the_trainer_module_8.docx | task-636-248 | 19 | [
[
120,
381,
207,
404
],
[
212,
381,
239,
404
],
[
245,
381,
295,
404
],
[
120,
418,
137,
438
],
[
141,
418,
226,
438
],
[
230,
418,
286,
438
],
[
120,
442,
134,
460
],
[
18... | [
[
120,
381,
207,
404
],
[
212,
381,
239,
404
],
[
245,
381,
295,
404
],
[
120,
418,
137,
438
],
[
141,
418,
226,
438
],
[
230,
418,
286,
438
],
[
120,
442,
134,
460
],
[
18... |
to transit countries), and stopping terrorists, Each individual seeking to return to Australia violent extremist propaganda and weapons would be managed on a case-by-case basis. from entering Australia. This may involve the use of several disruption approaches. Agencies may stop these people from travelling by cancelli... | to transit countries), and stopping terrorists, violent extremist propaganda and weapons from entering Australia. Agencies may stop these people from travelling by cancelling passports, undertaking biometric identity checking processes at the border or imposing strict visa controls. Preventing potential foreign fighter... | 0.776396 | [
0,
1,
2,
3,
4,
5,
13,
14,
15,
16,
17,
25,
26,
27,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
53,
54,
55,
56,
57,
58,
64,
65,
66,
67,
68,
69,
81,
82,
83,
84,
85,
92,
93,
94,
95,
96,
103,
104,
105,
106,
107,
114,
... | Australias-Counter-Terrorism-Strategy-2015.docx | task-636-257 | 21 | [
[
120,
84,
136,
102
],
[
140,
84,
188,
102
],
[
192,
84,
272,
102
],
[
276,
84,
304,
102
],
[
308,
84,
372,
102
],
[
377,
84,
449,
102
],
[
530,
84,
565,
102
],
[
570,
... | [
[
120,
84,
136,
102
],
[
140,
84,
188,
102
],
[
192,
84,
272,
102
],
[
276,
84,
304,
102
],
[
308,
84,
372,
102
],
[
377,
84,
449,
102
],
[
120,
102,
171,
120
],
[
175,
... |
Analytical and Analytical and Capacity Development Partnership (ACDP) Six Monthly Progress Report, Mid-2014, 2014 Six Monthly Progress Report, End-2014, 2015 Six Monthly Progress Report, Mid-2015, 2015 ACDP 001 Early Childhood Development Strategy Study, 2013 – ACDP 004 General Senior Secondary Education Financing in I... | Analytical and Analytical and Capacity Development Partnership (ACDP) Six Monthly Progress Report, Mid-2014, 2014 Six Monthly Progress Report, End-2014, 2015 Six Monthly Progress Report, Mid-2015, 2015 ACDP 001 – Early Childhood Development Strategy Study, 2013 ACDP 004 – General Senior Secondary Education Financing in... | 0.793002 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
34,
28,
29,
30,
31,
32,
33,
35,
36,
45,
37,
38,
39,
40,
41,
42,
43,
44,
46,
47,
48,
49,
50,
51,
52,
53,
54... | australias-education-partnership-with-indonesia-annual-performance-report-2015.docx | task-636-260 | 110 | [
[
130,
91,
205,
109
],
[
209,
91,
238,
109
],
[
243,
91,
318,
109
],
[
322,
91,
351,
109
],
[
356,
91,
421,
109
],
[
425,
91,
529,
109
],
[
533,
91,
622,
109
],
[
627,
... | [
[
130,
91,
205,
109
],
[
209,
91,
238,
109
],
[
243,
91,
318,
109
],
[
322,
91,
351,
109
],
[
356,
91,
421,
109
],
[
425,
91,
529,
109
],
[
533,
91,
622,
109
],
[
627,
... |
Funding White Ribbon Australia to increase their engagement with Indigenous and culturally and linguistically diverse communities, including new and emerging communities. Our Watch and Victorian Health will work with Australia’s National Research Organisation for Women’s Safety to develop the national primary preventio... | Funding White Ribbon Australia to increase their engagement with Indigenous and culturally and linguistically diverse communities, including new and emerging communities. Our Watch and Victorian Health will work with Australia’s National Research Organisation for Women’s Safety to develop the national primary preventio... | 0.956806 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Australias-Sixth-Report-under-the-ICCPR.docx | task-636-272 | 21 | [
[
137,
105,
206,
125
],
[
211,
105,
261,
125
],
[
266,
105,
326,
125
],
[
330,
105,
406,
125
],
[
411,
105,
427,
125
],
[
432,
105,
499,
125
],
[
505,
105,
542,
125
],
[
54... | [
[
137,
105,
206,
125
],
[
211,
105,
261,
125
],
[
266,
105,
326,
125
],
[
330,
105,
406,
125
],
[
411,
105,
427,
125
],
[
432,
105,
499,
125
],
[
505,
105,
542,
125
],
[
54... |
Variable support mixed provided, lengths of depending on Integrative Regional admission the residents flatshare Private (assed (Housing (Integrative Varies Adults Mixed according varies assistance, to the free time needs of assistance, the mobile individual assistance) Varies up Variable to 11 support (Caritas Regional... | Integrative flatshare (Integrative Varies Adults Mixed Variable support provided, depending on the residents (Housing assistance, free time assistance, mobile assistance) Private Regional mixed lengths of admission (assed according to the needs of the individual varies Flat Share Varies up to 11 (Caritas Vienna), 9 for... | 0.090392 | [
8,
13,
17,
18,
19,
20,
0,
1,
3,
6,
7,
11,
12,
16,
23,
26,
27,
30,
32,
34,
14,
9,
2,
4,
5,
10,
15,
21,
24,
25,
28,
29,
31,
33,
22,
44,
45,
35,
36,
38,
39,
41,
46,
52,
53,
59,
63,
54,
49,
56,
37,
40,
43,
50,
51... | austria-services-mapping-independent-living-at.docx | task-636-313 | 6 | [
[
466,
120,
520,
145
],
[
466,
142,
516,
168
],
[
727,
154,
767,
179
],
[
466,
165,
528,
190
],
[
727,
176,
775,
202
],
[
780,
176,
792,
202
],
[
466,
187,
535,
213
],
[
53... | [
[
91,
199,
164,
224
],
[
91,
221,
149,
246
],
[
91,
244,
170,
269
],
[
234,
244,
275,
269
],
[
310,
244,
351,
269
],
[
371,
244,
409,
269
],
[
466,
120,
520,
145
],
[
466,
... |
(and not in an institution or In this model, assistant living), using no the user is also support services (i.e. 24 responsible for payroll No data hours care) and living a accounting and available on the determined life (no replacement staff in case usage of solicitor). The Province of of sick leave. personal Vienna p... | (and not in an institution or assistant living), using no support services (i.e. 24 hours care) and living a life (no solicitor). The Province of Vienna provides these services already at care needs of 120 hours of care. Providers are NGOs (such as the Caritas) and private companies. Services are funded by the Province... | 0.422159 | [
0,
1,
2,
3,
4,
5,
9,
10,
11,
12,
17,
18,
19,
20,
26,
27,
28,
29,
30,
37,
38,
45,
46,
47,
48,
53,
54,
55,
57,
58,
59,
60,
62,
63,
64,
65,
66,
67,
71,
72,
73,
74,
75,
78,
79,
80,
81,
84,
85,
86,
88,
89,
90,
91,
... | austria-services-mapping-independent-living-at.docx | task-636-313 | 16 | [
[
414,
120,
444,
145
],
[
448,
120,
470,
145
],
[
474,
120,
486,
145
],
[
491,
120,
507,
145
],
[
511,
120,
577,
145
],
[
582,
120,
595,
145
],
[
685,
120,
699,
145
],
[
71... | [
[
414,
120,
444,
145
],
[
448,
120,
470,
145
],
[
474,
120,
486,
145
],
[
491,
120,
507,
145
],
[
511,
120,
577,
145
],
[
582,
120,
595,
145
],
[
414,
146,
472,
171
],
[
47... |
Australian Heritage Council Foster partnerships with jurisdictions, peak Universities bodies and academic institutions to access CSIRO current research to inform the identification of Heritage Officials of National Heritage values. Australia and New Department of the This includes reviewing the National Zealand Environ... | Australian Heritage Council Foster partnerships with jurisdictions, peak bodies and academic institutions to access current research to inform the identification of National Heritage values. This includes reviewing the National Environmental Science Programme priorities to facilitate greater consideration of National a... | 0.803206 | [
0,
1,
2,
3,
4,
5,
6,
7,
9,
10,
11,
12,
13,
14,
16,
17,
18,
19,
20,
21,
22,
26,
27,
28,
35,
36,
37,
38,
39,
42,
43,
44,
45,
46,
49,
50,
51,
52,
53,
54,
59,
60,
61,
62,
63,
64,
67,
68,
69,
70,
71,
72,
47,
32,
3... | australian-heritage-strategy-2015.docx | task-636-35 | 13 | [
[
632,
88,
693,
104
],
[
696,
88,
747,
104
],
[
632,
105,
676,
121
],
[
68,
142,
105,
158
],
[
108,
142,
184,
158
],
[
187,
142,
214,
158
],
[
217,
142,
293,
158
],
[
296,
... | [
[
632,
88,
693,
104
],
[
696,
88,
747,
104
],
[
632,
105,
676,
121
],
[
68,
142,
105,
158
],
[
108,
142,
184,
158
],
[
187,
142,
214,
158
],
[
217,
142,
293,
158
],
[
296,
... |
Heritage place managers and community groups raise awareness of the important heritage stories associated with these places within the Australian community. This new funding will help Australians and international visitors gain an improved understanding and appreciation of many of Australia’s important heritage stories... | Heritage place managers and community groups raise awareness of the important heritage stories associated with these places within the Australian community. This new funding will help Australians and international visitors gain an improved understanding and appreciation of many of Australia’s important heritage stories... | 0.669641 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
59... | australian-heritage-strategy-2015.docx | task-636-35 | 27 | [
[
58,
46,
115,
63
],
[
119,
46,
154,
63
],
[
158,
46,
223,
63
],
[
227,
46,
252,
63
],
[
255,
46,
331,
63
],
[
334,
46,
380,
63
],
[
383,
46,
415,
63
],
[
419,
46,
... | [
[
58,
46,
115,
63
],
[
119,
46,
154,
63
],
[
158,
46,
223,
63
],
[
227,
46,
252,
63
],
[
255,
46,
331,
63
],
[
334,
46,
380,
63
],
[
383,
46,
415,
63
],
[
419,
46,
... |
operational decisions for the conservation of heritage places and assets. The development of additional frameworks to further enhance heritage guidance will also be explored over the next few years. A significant challenge facing heritage managers is the difficulty in understanding the ongoing condition of their places... | operational decisions for the conservation of heritage places and assets. The development of additional frameworks to further enhance heritage guidance will also be explored over the next few years. A significant challenge facing heritage managers is the difficulty in understanding the ongoing condition of their places... | 0.816586 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | australian-heritage-strategy-2015.docx | task-636-35 | 29 | [
[
58,
46,
135,
63
],
[
139,
46,
200,
63
],
[
204,
46,
223,
63
],
[
227,
46,
249,
63
],
[
252,
46,
338,
63
],
[
342,
46,
356,
63
],
[
359,
46,
414,
63
],
[
418,
46,
... | [
[
58,
46,
135,
63
],
[
139,
46,
200,
63
],
[
204,
46,
223,
63
],
[
227,
46,
249,
63
],
[
252,
46,
338,
63
],
[
342,
46,
356,
63
],
[
359,
46,
414,
63
],
[
418,
46,
... |
Boarding Weekend Schedule Autumn Term 2018 Form 8 Leadership Weekend Friday 31st August Sunday 2nd September – Form 6 Camp to Ford Castle, Northumberland Friday 14th Sunday 16th September – Form 7 France Trip to La Grand Ferme,, normandie Friday 21st Monday 24th September – Form 5 Boarding Weekend Friday 28th Sunday 30... | Boarding Weekend Schedule Autumn Term 2018 Form 8 Leadership Weekend Friday 31st August – Sunday 2nd September Form 6 Camp to Ford Castle, Northumberland Friday 14th – Sunday 16th September Form 7 France Trip to La Grand Ferme,, normandie Friday 21st – Monday 24th September Form 5 Boarding Weekend Friday 28th – Sunday ... | 0.601436 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
16,
13,
14,
15,
17,
18,
19,
20,
21,
22,
23,
24,
25,
29,
26,
27,
28,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
44,
41,
42,
43,
45,
46,
47,
48,
49,
50,
54,
51,
52,
53... | aut-term-2018-bwes.docx | task-636-445 | 0 | [
[
178,
115,
397,
154
],
[
411,
115,
605,
154
],
[
618,
115,
821,
154
],
[
298,
161,
483,
200
],
[
496,
161,
604,
200
],
[
618,
161,
701,
200
],
[
324,
239,
391,
262
],
[
39... | [
[
178,
115,
397,
154
],
[
411,
115,
605,
154
],
[
618,
115,
821,
154
],
[
298,
161,
483,
200
],
[
496,
161,
604,
200
],
[
618,
161,
701,
200
],
[
324,
239,
391,
262
],
[
39... |
February 2017 Australian Catholic University TAFE NSW Aviation Australia TAFE Queensland Bond University TAFE SA Box Hill Institute TAFE Tasmanian Polytechnic Bureau of Meteorology The Australian National University Canberra Institute of Technology The Gordon Institute of TAFE Carnegie Mellon University The University ... | February 2017 Australian Catholic University Aviation Australia Bond University Box Hill Institute TAFE Bureau of Meteorology Canberra Institute of Technology Carnegie Mellon University Central Queensland University Charles Darwin University Charles Sturt University Chisholm Institute of TAFE Curtin University of Techn... | 0.538374 | [
0,
1,
2,
3,
4,
7,
8,
11,
12,
15,
16,
17,
18,
21,
22,
23,
28,
29,
30,
31,
37,
38,
39,
44,
45,
46,
51,
52,
53,
59,
60,
61,
70,
71,
72,
73,
78,
79,
80,
81,
86,
87,
92,
93,
94,
100,
101,
105,
106,
110,
111,
116,
117,... | australian-institutions.docx | task-636-55 | 0 | [
[
47,
244,
153,
269
],
[
160,
244,
215,
269
],
[
59,
301,
134,
317
],
[
138,
301,
199,
317
],
[
204,
301,
277,
317
],
[
452,
301,
495,
317
],
[
500,
301,
539,
317
],
[
59,
... | [
[
47,
244,
153,
269
],
[
160,
244,
215,
269
],
[
59,
301,
134,
317
],
[
138,
301,
199,
317
],
[
204,
301,
277,
317
],
[
59,
321,
119,
338
],
[
123,
321,
189,
338
],
[
59,
... |
References Albrecht, H. and Schlumberger, O. 2004. for Godot”: Regime Change without ““Waiting Democratization in the Middle East”, 25 (4): International Political Science Review Allison, R. 2008. Regionalism, Regional Structures and Regime Security in Central “Virtual Asia”, 27(2): 185-202. Central Asian Survey Ambros... | References Albrecht, H. and Schlumberger, O. 2004. ““Waiting for Godot”: Regime Change without Democratization in the Middle East”, International Political Science Review 25 (4): Allison, R. 2008. “Virtual Regionalism, Regional Structures and Regime Security in Central Asia”, Central Asian Survey 27(2): 185-202. Ambros... | 0.601619 | [
0,
1,
2,
3,
4,
5,
6,
12,
7,
8,
9,
10,
11,
13,
14,
15,
16,
17,
20,
21,
22,
23,
18,
19,
24,
25,
26,
35,
27,
28,
29,
30,
31,
32,
33,
34,
36,
39,
40,
41,
37,
38,
42,
43,
44,
51,
45,
52,
46,
47,
48,
49,
50,
53,
54... | AUTHORITARIAN_REGIMES_IN_DEMOCRATIC_REGIONAL_ORGANIZATIONS_revised_.docx | task-636-695 | 25 | [
[
120,
83,
214,
103
],
[
120,
128,
196,
147
],
[
201,
128,
221,
147
],
[
226,
128,
255,
147
],
[
260,
128,
378,
147
],
[
383,
128,
402,
147
],
[
407,
128,
453,
147
],
[
546... | [
[
120,
83,
214,
103
],
[
120,
128,
196,
147
],
[
201,
128,
221,
147
],
[
226,
128,
255,
147
],
[
260,
128,
378,
147
],
[
383,
128,
402,
147
],
[
407,
128,
453,
147
],
[
458... |
Authorization of the President Schedule of Board of Governors and Board of Trustees Policies Authority BOG Regulations and Guidelines UF Regulations BOT Resolutions Academic and Research Authorities of the President 2.002 7.051 (general) 2.003 7.055 3.006 7.056 8.002 7.0561 8.004 7.0562 8.009 7.0565 8.015 10.014 10.015... | Authorization of the President Schedule of Board of Governors and Board of Trustees Policies Authority BOG Regulations and Guidelines UF Regulations BOT Resolutions Academic and Research Authorities of the President (general) 2.002 2.003 3.006 8.002 8.004 8.009 8.015 10.014 10.015 7.051 7.055 7.056 7.0561 7.0562 7.0565... | 0.784942 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
32,
30,
33,
35,
37,
39,
41,
43,
44,
45,
31,
34,
36,
38,
40,
42,
46,
47,
48,
49,
50,
51,
52,
53,
54... | Authorization-of-the-President.docx | task-636-863 | 0 | [
[
388,
56,
489,
88
],
[
493,
56,
508,
88
],
[
512,
56,
537,
88
],
[
541,
56,
611,
88
],
[
271,
88,
337,
120
],
[
341,
88,
356,
120
],
[
360,
88,
404,
120
],
[
408,
88,
... | [
[
388,
56,
489,
88
],
[
493,
56,
508,
88
],
[
512,
56,
537,
88
],
[
541,
56,
611,
88
],
[
271,
88,
337,
120
],
[
341,
88,
356,
120
],
[
360,
88,
404,
120
],
[
408,
88,
... |
Anoxic Zones/ gallons Tanks Anaerobic gallons Sequencing Batch -- gallons Reactor (SBR) Membrane Bioreactor -- gallons (MBR) Secondary ft diameter; ft Circular Clarifier side water depth Secondary square feet; ft Rectangular Clarifier side water depth Other TERTIARY TREATMENT Calculations No. of Plan Sheet Specificatio... | Anoxic Zones/ Tanks gallons Anaerobic gallons Sequencing Batch Reactor (SBR) -- gallons Membrane Bioreactor (MBR) -- gallons Secondary Clarifier Circular ft diameter; ft side water depth Secondary Clarifier Rectangular square feet; ft side water depth Other TERTIARY TREATMENT Treatment Unit No. of Units Type Size per U... | 0.359371 | [
0,
1,
3,
2,
4,
5,
6,
7,
10,
11,
8,
9,
12,
13,
16,
14,
15,
17,
22,
21,
18,
19,
20,
23,
24,
25,
26,
31,
30,
27,
28,
29,
32,
33,
34,
35,
36,
37,
44,
45,
39,
40,
51,
46,
47,
48,
49,
41,
42,
52,
43,
53,
38,
50,
54... | Authorization-to-construct-application-2018.docx | task-636-872 | 7 | [
[
146,
164,
194,
181
],
[
198,
164,
243,
181
],
[
537,
171,
584,
188
],
[
175,
179,
215,
195
],
[
161,
194,
229,
211
],
[
537,
201,
584,
218
],
[
135,
223,
212,
240
],
[
21... | [
[
146,
164,
194,
181
],
[
198,
164,
243,
181
],
[
175,
179,
215,
195
],
[
537,
171,
584,
188
],
[
161,
194,
229,
211
],
[
537,
201,
584,
218
],
[
135,
223,
212,
240
],
[
21... |
Anoxic gallons Tanks Anaerobic gallons Zones/Tanks Sequencing Batch -- gallons Reactor (SBR) Membrane -- gallons Bioreactor (MBR) Secondary ft diameter; ft Circular Clarifier side water depth Secondary square feet; ft Rectangular Clarifier side water depth Other TERTIARY TREATMENT Calculations No. of Plan Sheet Specifi... | Anoxic Tanks gallons Anaerobic Zones/Tanks gallons Sequencing Batch Reactor (SBR) -- gallons Membrane Bioreactor (MBR) -- gallons Secondary Clarifier Circular ft diameter; ft side water depth Secondary Clarifier Rectangular square feet; ft side water depth Other TERTIARY TREATMENT Treatment Unit No. of Units Type Size ... | 0.358994 | [
0,
2,
1,
3,
5,
4,
6,
7,
10,
11,
8,
9,
12,
15,
16,
13,
14,
17,
22,
21,
18,
19,
20,
23,
24,
25,
26,
31,
30,
27,
28,
29,
32,
33,
34,
35,
36,
37,
44,
45,
39,
40,
51,
46,
47,
48,
49,
41,
42,
52,
43,
53,
38,
50,
54... | Authorization-to-Construct-Application-2018_v2.docx | task-636-873 | 7 | [
[
151,
164,
199,
181
],
[
537,
171,
585,
188
],
[
175,
179,
215,
195
],
[
161,
194,
229,
211
],
[
537,
201,
585,
218
],
[
153,
208,
237,
225
],
[
136,
223,
212,
240
],
[
21... | [
[
151,
164,
199,
181
],
[
175,
179,
215,
195
],
[
537,
171,
585,
188
],
[
161,
194,
229,
211
],
[
153,
208,
237,
225
],
[
537,
201,
585,
218
],
[
136,
223,
212,
240
],
[
21... |
Section One Awareness – Action Output / Outcome Measure Responsibility Timescale User / Carer Defined Outcome 1.1.1. Successful launch event delivered; attended by people with autism, their families and carers May 2013 and other representatives from DHSSPS to lead both the public and voluntary Launch Strategy with inpu... | Section One – Awareness Action Output / Outcome Measure Responsibility Timescale User / Carer Defined Outcome Launch Strategy and Action Plan 1.1.1. Successful launch event delivered; attended by people with autism, their families and carers and other representatives from both the public and voluntary sectors. DHSSPS t... | 0.562351 | [
0,
1,
3,
2,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
44,
45,
51,
52,
53,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
32,
33,
34,
35,
39,
40,
41,
42,
43,
50,
36,
37,
38,
46,
47,
48,
49,
54,
30,
31... | Autism%20Strategy%20(2013-2020)%20%20Action%20Plan%20(2013-2015)%20(3)%20(3).docx | task-637-105 | 40 | [
[
59,
149,
111,
177
],
[
115,
149,
142,
177
],
[
158,
149,
233,
177
],
[
146,
152,
154,
175
],
[
59,
213,
104,
241
],
[
241,
213,
288,
241
],
[
292,
213,
296,
241
],
[
300,... | [
[
59,
149,
111,
177
],
[
115,
149,
142,
177
],
[
146,
152,
154,
175
],
[
158,
149,
233,
177
],
[
59,
213,
104,
241
],
[
241,
213,
288,
241
],
[
292,
213,
296,
241
],
[
300,... |
The College grading policy should be included in the course syllabus. Any Grading: special practices should also go here. This should include the instructor’s and/or the department’s policy for make-up work. For example in a speech course, not “Speeches given on due date will receive no grade higher than a sixty” or wo... | Grading: The College grading policy should be included in the course syllabus. Any special practices should also go here. This should include the instructor’s and/or the department’s policy for make-up work. For example in a speech course, “Speeches not given on due date will receive no grade higher than a sixty” or “M... | 0.86235 | [
12,
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
38,
37,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
55,
52,
53... | AUTO%201614%20MS%202016.docx | task-637-252 | 1 | [
[
255,
44,
285,
64
],
[
290,
44,
351,
64
],
[
356,
44,
416,
64
],
[
421,
44,
470,
64
],
[
475,
44,
527,
64
],
[
532,
44,
550,
64
],
[
555,
44,
623,
64
],
[
628,
44,
... | [
[
176,
45,
250,
65
],
[
255,
44,
285,
64
],
[
290,
44,
351,
64
],
[
356,
44,
416,
64
],
[
421,
44,
470,
64
],
[
475,
44,
527,
64
],
[
532,
44,
550,
64
],
[
555,
44,
... |
onto the diagnosis or in descriptions of the lesion Any heading that pertains to CLINICAL NOTES, the history of CLINICAL the patient (or DETAILS, the specimen if CLINICAL no specimen HISTORY heading included) Any heading SPECIMEN, that pertains to SPECIMEN Specimen. LABELLED Any heading MACROSCOPIC, that pertains to MA... | onto the diagnosis or in descriptions of the lesion Any heading that pertains to the history of the patient (or the specimen if no specimen heading included) CLINICAL NOTES, CLINICAL DETAILS, CLINICAL HISTORY Any heading that pertains to Specimen. SPECIMEN, SPECIMEN LABELLED Any heading that pertains to the Macroscopic... | 0.651809 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
16,
17,
18,
20,
21,
22,
24,
25,
26,
28,
29,
31,
32,
14,
15,
19,
23,
27,
30,
33,
34,
36,
37,
38,
40,
35,
39,
41,
42,
43,
45,
46,
47,
49,
51,
53,
44,
48,
50,
52,
54... | Auto%20Pop%20Project%20Report%20Stage.docx | task-637-271 | 12 | [
[
246,
84,
270,
97
],
[
274,
84,
290,
97
],
[
246,
95,
297,
108
],
[
300,
95,
312,
108
],
[
315,
95,
325,
108
],
[
246,
106,
311,
119
],
[
315,
106,
326,
119
],
[
246,
... | [
[
246,
84,
270,
97
],
[
274,
84,
290,
97
],
[
246,
95,
297,
108
],
[
300,
95,
312,
108
],
[
315,
95,
325,
108
],
[
246,
106,
311,
119
],
[
315,
106,
326,
119
],
[
246,
... |
OVERSIZE, OVERWEIGHT OR EXCESS LUGGAGE: PAYMENTS: PORT ACCESS: REFUND POLICY: Per WAC 480-30-356, to the exceptions of (d)(ii) and (iii) of this “Subject subsection unused tickets will be redeemed at the purchase price and unused portions of round-trip or commutation tickets will be redeemed by charging the regular far... | OVERSIZE, OVERWEIGHT OR EXCESS LUGGAGE: PAYMENTS: PORT ACCESS: REFUND POLICY: Per WAC 480-30-356, “Subject to the exceptions of (d)(ii) and (iii) of this subsection unused tickets will be redeemed at the purchase price and unused portions of round-trip or commutation tickets will be redeemed by charging the regular far... | 0.889376 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
22,
13,
14,
15,
16,
17,
18,
19,
20,
21,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54... | AUTO%20TRANSPORTATION%20TARIFF%20TEMPLATE%20-%202017.docx | task-637-286 | 4 | [
[
105,
169,
212,
190
],
[
216,
169,
357,
190
],
[
362,
169,
391,
190
],
[
396,
169,
472,
190
],
[
477,
169,
584,
190
],
[
105,
204,
222,
225
],
[
105,
238,
160,
259
],
[
16... | [
[
105,
169,
212,
190
],
[
216,
169,
357,
190
],
[
362,
169,
391,
190
],
[
396,
169,
472,
190
],
[
477,
169,
584,
190
],
[
105,
204,
222,
225
],
[
105,
238,
160,
259
],
[
16... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.