Trial Outcomes & Findings for RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR (NCT NCT02255422)
NCT ID: NCT02255422
Last Updated: 2025-06-05
Results Overview
Cycle ergometry using a stationary recumbent bike was used to conduct maximal exercise testing. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion). Change of peak workload during exercise testing was measured at baseline, Week 4, and Week 12. Change from baseline at Week 12 reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-06-05
Participant Flow
First patient enrolled 5-May-2015, last patient completed 30-Nov-2017
Participant milestones
| Measure |
Placebo
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
13
|
6
|
5
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
n=6 Participants
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
n=10 Participants
Omaveloxolone (RTA 408) 160 mg capsules administered once daily for 12 weeks
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 Years
STANDARD_DEVIATION 11.86 • n=39 Participants
|
52.3 Years
STANDARD_DEVIATION 9.61 • n=41 Participants
|
49.8 Years
STANDARD_DEVIATION 14.05 • n=35 Participants
|
45.5 Years
STANDARD_DEVIATION 14.08 • n=31 Participants
|
45.2 Years
STANDARD_DEVIATION 4.71 • n=146 Participants
|
30.7 Years
STANDARD_DEVIATION 10.25 • n=19 Participants
|
39.8 Years
STANDARD_DEVIATION 15.27 • n=147 Participants
|
42.9 Years
STANDARD_DEVIATION 13.01 • n=193 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
32 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
21 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
6 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
7 Participants
n=147 Participants
|
47 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Three patients out of the 53 total were excluded from the analysis set. One each from the 20 mg arm and the 160 mg arm were excluded because they did not have post-baseline efficacy assessments. One patient from the placebo arm was excluded from analysis because their baseline maximal exercise test duration \< 4 min and was not considered valid.
Cycle ergometry using a stationary recumbent bike was used to conduct maximal exercise testing. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion). Change of peak workload during exercise testing was measured at baseline, Week 4, and Week 12. Change from baseline at Week 12 reported.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
n=5 Participants
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
n=9 Participants
Omaveloxolone (RTA 408) 160 mg capsules administered once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change of Peak Workload (in Watts/kg) During Exercise Testing
|
0.0090 Watts/kg
Standard Error 0.0388
|
0.020 Watts/kg
Standard Error 0.0544
|
-0.0300 Watts/kg
Standard Error 0.0544
|
0.1050 Watts/kg
Standard Error 0.0596
|
-0.0520 Watts/kg
Standard Error 0.0544
|
-0.0660 Watts/kg
Standard Error 0.0544
|
0.0020 Watts/kg
Standard Error 0.0465
|
SECONDARY outcome
Timeframe: 6MWT was assessed at Week 4, Week 8, and Week 12 and compared to baselinePopulation: Three patients out of the 53 total were excluded from the analysis set. One each from the 20 mg arm and the 160 mg arm were excluded because they did not have post-baseline efficacy assessments. One patient from the placebo arm was excluded from analysis because their baseline maximal exercise test duration \< 4 min and was not considered valid.
Patients were instructed to walk as far as they could along a marked path for 6 minutes. Distance walked was measured. If patients used a cane or walking assist device at Screening, the same walking assist device was to be used for all 6MWT assessments.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
n=6 Participants
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
n=6 Participants
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
n=5 Participants
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
n=6 Participants
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
n=6 Participants
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
n=9 Participants
Omaveloxolone (RTA 408) 160 mg capsules administered once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change in 6-minute Walk Test (6MWT) Distance
Week 4
|
40.462 Meters
Standard Error 10.0539
|
19.333 Meters
Standard Error 14.9658
|
18.2500 Meters
Standard Error 14.9658
|
-9.2000 Meters
Standard Error 16.3942
|
-11.6670 Meters
Standard Error 14.9658
|
9.9170 Meters
Standard Error 14.9658
|
10.8330 Meters
Standard Error 12.2195
|
|
Change in 6-minute Walk Test (6MWT) Distance
Week 8
|
24.923 Meters
Standard Error 9.9381
|
12.865 Meters
Standard Error 15.7374
|
33.9170 Meters
Standard Error 15.1418
|
13.8000 Meters
Standard Error 16.5870
|
11.0000 Meters
Standard Error 15.1418
|
17.5830 Meters
Standard Error 15.1418
|
28.9440 Meters
Standard Error 12.3633
|
|
Change in 6-minute Walk Test (6MWT) Distance
Week 12
|
29.846 Meters
Standard Error 12.9276
|
17.167 Meters
Standard Error 19.6519
|
17.7500 Meters
Standard Error 19.6519
|
28.2000 Meters
Standard Error 21.5275
|
-7.833 Meters
Standard Error 19.6519
|
6.2500 Meters
Standard Error 19.6519
|
8.5710 Meters
Standard Error 16.4721
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Omaveloxolone Capsules 2.5 and 5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Omaveloxolone Capsules 10 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Omaveloxolone Capsules 20 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Omaveloxolone Capsules 40 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Omaveloxolone Capsules 80 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Omaveloxolone Capsules 160 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
n=10 participants at risk
Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Tonic epileptic seizure
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Cardiac disorders
Wide complex tachycardia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Right sided hemiparesis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Exacerbated fatigue
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
Placebo capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 2.5 and 5 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 2.5 mg capsules administered orally once daily for 2 weeks then 5 mg administered orally once daily for 10 weeks
|
Omaveloxolone Capsules 10 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 10 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 20 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 20 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 40 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 40 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 80 mg
n=6 participants at risk
Omaveloxolone (RTA 408) 80 mg capsules administered orally once daily for 12 weeks
|
Omaveloxolone Capsules 160 mg
n=10 participants at risk
Omaveloxolone (RTA 408) 160 mg capsules administered orally once daily for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Myoclonus
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Psychiatric disorders
Tachyphrenia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Surgical and medical procedures
Eyelid operation
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Eye disorders
Diplopia
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
33.3%
2/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
20.0%
2/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
20.0%
2/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
20.0%
2/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Fatigue
|
30.8%
4/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
50.0%
3/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Feeling abnormal
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Asthenia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Energy increased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Malaise
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
2/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
30.0%
3/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
20.0%
2/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Fungal infection
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Sialoadenitis
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Blister infected
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Localised infection
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Consussion
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Blood pressure increased
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Electrocardiogram PR prologation
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Hepatic enzyme increased
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Electrocardiogram T wave amplitude decreased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Investigations
Weight increased
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
33.3%
2/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.1%
3/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
66.7%
4/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
33.3%
2/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
33.3%
2/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Restless leg syndrome
|
7.7%
1/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
10.0%
1/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Head titubation
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
16.7%
1/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/6 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
0.00%
0/10 • 16 weeks
Significant adverse events are collected from the time of the first dose of study drug until the final visit or 30 days following final study dose for patients who terminated early. Both investigator assessment/questioning (systematic) and patient self reporting (non-systematic) are used in this study but were reported by the investigators as a consolidated number and are reported below as systematic.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER