Trial Outcomes & Findings for Long-Term Safety Study of Tafenoquine (NCT NCT03320174)
NCT ID: NCT03320174
Last Updated: 2026-04-17
Results Overview
Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
600 participants
Primary outcome timeframe
After 12 months of exposure to study drug
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
301
|
299
|
|
Overall Study
COMPLETED
|
193
|
211
|
|
Overall Study
NOT COMPLETED
|
108
|
88
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One less subject was not included in the safety population due to early withdrawal
Baseline characteristics by cohort
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=301 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=299 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=301 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=600 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
301 Participants
n=301 Participants
|
299 Participants
n=299 Participants
|
600 Participants
n=600 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=301 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=600 Participants
|
|
Age, Continuous
|
31.1 years
n=301 Participants
|
31.6 years
n=299 Participants
|
31.3 years
n=600 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=301 Participants • One less subject was not included in the safety population due to early withdrawal
|
182 Participants
n=298 Participants • One less subject was not included in the safety population due to early withdrawal
|
372 Participants
n=599 Participants • One less subject was not included in the safety population due to early withdrawal
|
|
Sex: Female, Male
Male
|
111 Participants
n=301 Participants • One less subject was not included in the safety population due to early withdrawal
|
116 Participants
n=298 Participants • One less subject was not included in the safety population due to early withdrawal
|
227 Participants
n=599 Participants • One less subject was not included in the safety population due to early withdrawal
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=301 Participants
|
3 Participants
n=299 Participants
|
4 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=301 Participants
|
31 Participants
n=299 Participants
|
70 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=301 Participants
|
1 Participants
n=299 Participants
|
5 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=301 Participants
|
6 Participants
n=299 Participants
|
17 Participants
n=600 Participants
|
|
Race (NIH/OMB)
White
|
244 Participants
n=301 Participants
|
256 Participants
n=299 Participants
|
500 Participants
n=600 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=301 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=301 Participants
|
2 Participants
n=299 Participants
|
4 Participants
n=600 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=301 Participants
|
53 participants
n=299 Participants
|
109 participants
n=600 Participants
|
|
Region of Enrollment
Australia
|
245 participants
n=301 Participants
|
246 participants
n=299 Participants
|
491 participants
n=600 Participants
|
|
Central Subfield Thickness
|
268.09 um
STANDARD_DEVIATION 19.87 • n=301 Participants • One participant excluded due to early withdrawal
|
269.56 um
STANDARD_DEVIATION 18.72 • n=298 Participants • One participant excluded due to early withdrawal
|
268.82 um
STANDARD_DEVIATION 19.30 • n=599 Participants • One participant excluded due to early withdrawal
|
|
Total Macular Volume
|
8.78 mm
STANDARD_DEVIATION 0.38 • n=301 Participants • One participant excluded due to early withdrawal
|
8.78 mm
STANDARD_DEVIATION 0.35 • n=298 Participants • One participant excluded due to early withdrawal
|
8.78 mm
STANDARD_DEVIATION 0.36 • n=599 Participants • One participant excluded due to early withdrawal
|
|
Parafoveal (inner ring) retinal thickness
|
342.59 um
STANDARD_DEVIATION 14.70 • n=301 Participants • One participant excluded due to early withdrawal
|
344.21 um
STANDARD_DEVIATION 13.97 • n=298 Participants • One participant excluded due to early withdrawal
|
343.40 um
STANDARD_DEVIATION 14.35 • n=599 Participants • One participant excluded due to early withdrawal
|
|
Parafoveal (outer ring) retinal thickness
|
301.74 um
STANDARD_DEVIATION 15.09 • n=301 Participants • One participant excluded due to early withdrawal
|
301.87 um
STANDARD_DEVIATION 12.75 • n=298 Participants • One participant excluded due to early withdrawal
|
301.80 um
STANDARD_DEVIATION 13.97 • n=599 Participants • One participant excluded due to early withdrawal
|
|
Best Corrected Visual Accuity
|
60.2 letters
STANDARD_DEVIATION 3.55 • n=301 Participants • One participant excluded due to early withdrawal
|
59.92 letters
STANDARD_DEVIATION 3.64 • n=298 Participants • One participant excluded due to early withdrawal
|
60.06 letters
STANDARD_DEVIATION 3.60 • n=599 Participants • One participant excluded due to early withdrawal
|
PRIMARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population.
Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF.
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Serious Ophthalmic Safety Event
|
45 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population
Mean change from baseline in key SD OCT parameters including central subfield thickness, total macular volume, and parafoveal (inner ring of Early Treatment Diabetic Retinopathy Study, and retinal thickness. Clinically significant change from baseline for central subfield thickness \[change from baseline of at least 40 µm (15% change)\]. Clinically significant change from baseline for total macular volume \[change of \> 10% (0.86 mm3) from baseline\]. Clinically significant change from baseline for parafoveal (inner ring) retinal thickness \[change from baseline of at least 10 µm\]. Clinically significant change from baseline for qFAF (change in mid-ring qFAF unit from baseline of at least 12% in both eyes at the same visit).
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Mean Change From Baseline in Key SD OCT Parameters
Number of Subjects with Clinically Significant Change in Central Subfield Thickness
|
1 Participants
|
0 Participants
|
|
Number of Participants With Mean Change From Baseline in Key SD OCT Parameters
Number of Subjects with Clinically Significant Change in Total Macular Volume
|
3 Participants
|
0 Participants
|
|
Number of Participants With Mean Change From Baseline in Key SD OCT Parameters
Number of Subjects with Clinically Significant Change in Parafoveal (inner ring) Retinal Thickness
|
12 Participants
|
14 Participants
|
|
Number of Participants With Mean Change From Baseline in Key SD OCT Parameters
Number of Subjects with Clinically Significant Change in Mid Ring qFAF Patterns
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population
Any ellipsoid or interdigitating zone disruption within the ETDRS grid
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Ellipsoid or Interdigitating Zone Disruption
Number of Subjects with Abnormal Ellipsoid Zone
|
11 Participants
|
13 Participants
|
|
Number of Participants With Ellipsoid or Interdigitating Zone Disruption
Number of Subjects with Abnormal Interdigitization Zone
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population
Mean change from baseline in BCVA score, the number of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change \[≥ 3 lines\] of change in ETDRS BCVA at 4 meters).
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Mean Change From Baseline in Best Corrected Visual Acuity
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugSlit lamp examination was use to detect and grade corneal deposits (also known as vortex keratopathy or cornea verticillata) and retinal abnormalities arising from drug-induced phospholipidosis.
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Corneal Deposits From Slit Lamp Examination of the Corneal Epithelium
|
176 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugCorneal deposits as determined by digital corneal photographs that are indicative of cornea verticillata also known as vortex keratopathy
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With New Abnormalities Compared With Baseline Observed With Color Retinal Digital Photography
|
114 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Per protocol subjects
Microperimetry can be a useful tool for objective evaluation of macular function and progression of disease. Macular disease causes impairment of central vision, metamorphopsia, macropsia, micropsia and color vision defect. Microperimetry measures fixation stability which is associated with visual acuity.
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With New Abnormalities Compared With Baseline Observed With Microperimetry
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Per protocol subjects
Visual acuity was measured in a consistent way in order to detect any changes in vision as described in the Ophthalmic Reference Manual using a set of Early Treatment Diabetic Retinopathy Study (ETDRS) charts and a retro-illuminated box providing standardized illumination. Subjects are seated 4 meters from the letter chart and asked to read the letters. Letters read correctly count towards the total score. In addition, there are 5 letters in each of the 14 lines. The lines are of equal difficulty and follow a logarithmic progression of diminishing letter size related to the minimum angle of resolution. The endpoints include mean change from baseline in BCVA score, the proportion of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change \[≥ 3 lines\] of change in ETDRS BCVA at 4 meters).
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Any Clinically Significant Change in ETDRS BCVA (Defined as >15 Letter Change [≥ 3 Lines] of Change in ETDRS BCVA at 4 Meters)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Per protocol subjects
Color deficiency was assessed using the Farnsworth-Munsell 100 (FM-100) hue test
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Proportion of Participants Who Develop a Color Deficiency Using the Farnsworth-Munsell 100 (FM-100) Hue Test
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Per protocol subjects
The Mars letter contrast sensitivity test is a set of charts for testing peak visual contrast sensitivity. Subjects are asked to read to letters from left to right across the chart. The logarithm of contrast sensitivity (logCS) score is given by the log contrast sensitivity value at the lowest contrast letter just prior to two incorrectly identified letters, minus a scoring correction.
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=247 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=253 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Who Develop a Loss of 0.12 or Greater Logarithm of Contrast Sensitivity (logCS) on the Mars Letter Contrast Sensitivity Test
|
32 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Safety population
Psychiatric disorders were reported as adverse events
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=301 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=298 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Who Develop a Psychiatric Disorder in Accordance With DSM-5 as Assessed With the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 Assessment Questionnaire
|
61 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: After 12 months of exposure to study drugPopulation: Safety population
The period of observation for collection of AEs extended from the time of dosing (Day 1, Week 1 \[Visit 2\]) through the Week 64 follow-up visit. Proportion of participants with an AE of dizziness or vertigo are reported here.
Outcome measures
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=301 Participants
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=298 Participants
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With an AE of Dizziness or Vertigo and Severity as Assessed by the Dizziness Handicap Inventory
|
20 Participants
|
32 Participants
|
Adverse Events
Tafenoquine 200 mg (2 x 100 mg Tablets)
Serious events: 23 serious events
Other events: 274 other events
Deaths: 0 deaths
Placebo
Serious events: 17 serious events
Other events: 268 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=301 participants at risk
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=299 participants at risk
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Anorectal Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Cellulitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pneumonia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Viral Pericarditis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Weight Increased
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Obesity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Adjustment Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Depression
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Suicide Attempt
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Abortion Induced
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
Other adverse events
| Measure |
Tafenoquine 200 mg (2 x 100 mg Tablets)
n=301 participants at risk
Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Tafenoquine: Tafenoquine 200mg
|
Placebo
n=299 participants at risk
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks
Placebo: Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Atrioventricular Dissociation
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Cardiac disorders
Palpitations
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Eustachian Tube Dysfunction
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Vertigo
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Endocrine disorders
Goitre
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Endocrine disorders
Thyroid Mass
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Acute Macular Outer Retinopathy
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Asthenopia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Blepharitis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Blepharospasm
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Cataract Cortical
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Chalazion
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Cornea Opacity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Cornea Verticillata
|
54.5%
164/301 • Number of events 164 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
3.7%
11/299 • Number of events 11 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Cornea Verticillata (grade 2 or greater)
|
40.5%
122/301 • Number of events 122 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Corneal Deposits
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Corneal Erosion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Corneal Opacity
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Corneal Scar
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Deposit Eye
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Diplopia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Dry Eye
|
7.0%
21/301 • Number of events 21 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
6.7%
20/299 • Number of events 20 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Eczema Eyelids
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Eye Pain
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Eye Pruritus
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Eyelids Pruritus
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Hypermetropia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Iris Cyst
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Keratic Precipitates
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Lacrimation Increased
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Lenticular Opacities
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Loss of Visual Contrast Sensitivity
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Macular Cyst
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Meibomian Gland Dysfunction
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Metamorphopsia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Night Blindness
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Ocular Hyperaemia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Optic Disc Haemorrhage
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Periorbital Oedema
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Photokeratitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Photophobia
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.0%
6/299 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Pinguecula
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Presbyopia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Pterygium
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Punctate Keratitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Cyst
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Degeneration
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Deposits
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Disorder
|
7.0%
21/301 • Number of events 21 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
7.7%
23/299 • Number of events 23 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Exudates
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Retinal Haemorrhage
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Vision Blurred
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Visual Impairment
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
4.7%
14/301 • Number of events 14 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
3.0%
9/299 • Number of events 9 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
13/301 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.3%
10/301 • Number of events 10 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Anorectal Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Dental Caries
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
32/301 • Number of events 32 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
8.0%
24/299 • Number of events 24 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Flatulence
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Food Poisoning
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Gingival Discomfort
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Malpositioned Teeth
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
39/301 • Number of events 39 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
7.7%
23/299 • Number of events 23 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Oral Mucosal Blistering
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
12/301 • Number of events 12 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
3.7%
11/299 • Number of events 11 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Adverse Drug Reaction
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Adverse Food Reaction
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Asthenia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Chest Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Chills
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Complication Associated With Device
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Cyst
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Fatigue
|
4.0%
12/301 • Number of events 12 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.7%
8/299 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Hangover
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Inflammation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Malaise
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Medical Device Pain
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Medical Device Site Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Peripheral Swelling
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Pyrexia
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Sensation of Foreign Body
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Allergy to Animal
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Hypersensitivity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Immune system disorders
Seasonal Allergy
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Abscess of External Auditory Meatus
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Alveolar Osteitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Bacterial Infection
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Blastocystis Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Cellulitis
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Chlamydial Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Conjunctivitis Viral
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Covid-19
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Cystitis
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Ear Infection
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Enterobiasis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
External Ear Cellulitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Gastroenteritis
|
6.6%
20/301 • Number of events 20 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
7.0%
21/299 • Number of events 21 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Gonorrhoea
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Herpes Simplex
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Herpes Zoster
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Infectious Mononucleosis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Influenza
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Laryngitis
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Localised Infection
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Molluscum Contagiosum
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Oral Candidiasis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Otitis Externa
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Otitis Media Acute
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Paronychia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Parotitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pharyngitis
|
2.3%
7/301 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.7%
8/299 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pneumonia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Rhinitis
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Sinusitis
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Sinusitis Bacterial
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Staphylococcal Skin Infection
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Tonsillitis
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Tooth Infection
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
29.2%
88/301 • Number of events 88 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
35.8%
107/299 • Number of events 107 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
13/301 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
4.3%
13/299 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Viral Infection
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.0%
6/299 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Viral Pericarditis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
8.3%
25/301 • Number of events 25 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
7.7%
23/299 • Number of events 23 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Adverse Event Following Immunisation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Animal Scratch
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Chemical Eye Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Eye Contusion
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Foreign Body In Eye
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Nail Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Neck Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Neck Syndrome
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Repetitive Strain Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Injury, poisoning and procedural complications
Venomous Sting
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
4.0%
12/299 • Number of events 12 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Bilirubin Increased
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Creatinine Increased
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Pressure Diastolic Increased
|
2.3%
7/301 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Pressure Increased
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Pressure Systolic Increased
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Blood Testosterone Decreased
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Carbohydrate Tolerance Analyses (Incl Diabetes)
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Colour Vision Tests Abnormal
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Electrocardiogram PR Prolongation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Heart Rate Irregular
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Vascular Tests NEC (Incl Blood Pressure)
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Visual Acuity Tests Abnormal
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Visual Field Tests Abnormal
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
Weight Increased
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Investigations
White Blood Cells Urine
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Alcohol Intolerance
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Obesity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
9/301 • Number of events 9 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
14/301 • Number of events 14 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
5.0%
15/299 • Number of events 15 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
10/301 • Number of events 10 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
4.3%
13/299 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.7%
8/301 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Balance Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Cervicogenic Headache
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Disturbance In Attention
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Dizziness
|
6.6%
20/301 • Number of events 20 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
10.7%
32/299 • Number of events 32 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Dizziness Postural
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Dysgeusia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Headache
|
25.9%
78/301 • Number of events 78 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
27.1%
81/299 • Number of events 81 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Idiopathic Intracranial Hypertension
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Lethargy
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Migraine
|
2.7%
8/301 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.3%
7/299 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Migraine With Aura
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Neuralgia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Paraesthesia
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Parosmia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Presyncope
|
1.3%
4/301 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Sinus Headache
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Somnolence
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Syncope
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Tension Headache
|
4.3%
13/301 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Nervous system disorders
Pregnancy
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Abnormal Dreams
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Adjustment Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Alcohol Use Disorder
|
5.0%
15/301 • Number of events 15 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
4.3%
13/299 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Anxiety
|
2.3%
7/301 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.0%
6/299 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Panic Attack
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Panic Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Generalised Anxiety Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Social Anxiety Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Stress
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Binge Eating
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Bulimia Nervosa
|
2.3%
7/301 • Number of events 7 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Depression
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Depressive Symptom
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Major Depression
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.7%
8/299 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Mood Altered
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Mood Swings
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Persistent Depressive Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Disorientation
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Genito-Pelvic Pain/Penetration Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Hypervigilance
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Initial Insomnia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Insomnia
|
7.3%
22/301 • Number of events 22 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
6.7%
20/299 • Number of events 20 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Obsessive-Compulsive Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Restlessness
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.0%
9/301 • Number of events 9 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
4.3%
13/299 • Number of events 13 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Psychiatric disorders
Suicide Attempt
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Renal and urinary disorders
Dysuria
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Renal and urinary disorders
Pollakiuria
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Renal and urinary disorders
Urine Abnormality
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Genital Hyperaesthesia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Testicular Torsion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Reproductive system and breast disorders
Vulval Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.7%
5/299 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Irregular Breathing
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
3.3%
10/299 • Number of events 10 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Ulceration
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.00%
3/301 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.7%
8/299 • Number of events 8 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
2.0%
6/299 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.0%
6/301 • Number of events 6 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Ingrown Hair
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.3%
4/299 • Number of events 4 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
5/301 • Number of events 5 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Sebaceous Gland Disorder
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
1.0%
3/299 • Number of events 3 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Abortion Induced
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Artificial Crown Procedure
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Dental Implantation
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Lip Operation
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Vascular disorders
Flushing
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.67%
2/299 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Vascular disorders
Hypertension
|
0.66%
2/301 • Number of events 2 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Vascular disorders
Hypotension
|
0.00%
0/301 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.33%
1/299 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.33%
1/301 • Number of events 1 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
0.00%
0/299 • Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following: * detailed guidance on the collection, verification and presentation of AE/ADR reports arising from clinical trials on medicinal products for human use ('CT-3') (2011/C172/01); * ICH guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; and * ICH guideline E2F: Note for guidance on DSUR.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place