Trial Outcomes & Findings for Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis (NCT NCT01424670)
NCT ID: NCT01424670
Last Updated: 2019-05-15
Results Overview
SCC at 6 months was determined by the observation of a sputum specimen negative for growth of mycobacterium tuberculosis (MTB) using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the statistical analysis plan (SAP) was used to define a single representative result. Time to SCC was then defined as the interval between the date of first dose of IMP and the date of first of 2 consecutive negative single representative time points that were at least 25 days apart. The median time in days to SCC up to Month 6 is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
Month 6
Results posted on
2019-05-15
Participant Flow
511 participants were randomized to receive investigational medicinal product (IMP) and an optimized background treatment regimen (OBR) for 6 months, followed by OBR treatment alone for 12-18 months. The trial also included a post-treatment follow-up period of 6-12 months. Participants who stopped taking IMP and/or OBR could remain in the study.
Participant milestones
| Measure |
Delamanid + OBR
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 milligrams (mg) delamanid orally twice daily (BID) (morning and evening) + OBR for 2 months, followed by 200 mg delamanid once daily (QD) (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Placebo + OBR
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
|---|---|---|
|
6-Month Intensive Period (182 Days)
STARTED
|
341
|
170
|
|
6-Month Intensive Period (182 Days)
Received at Least 1 Dose of Study Drug
|
341
|
170
|
|
6-Month Intensive Period (182 Days)
COMPLETED
|
322
|
156
|
|
6-Month Intensive Period (182 Days)
NOT COMPLETED
|
19
|
14
|
|
Continuation Period
STARTED
|
322
|
156
|
|
Continuation Period
COMPLETED
|
288
|
142
|
|
Continuation Period
NOT COMPLETED
|
34
|
14
|
Reasons for withdrawal
| Measure |
Delamanid + OBR
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 milligrams (mg) delamanid orally twice daily (BID) (morning and evening) + OBR for 2 months, followed by 200 mg delamanid once daily (QD) (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Placebo + OBR
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
|---|---|---|
|
6-Month Intensive Period (182 Days)
Adverse Event
|
2
|
2
|
|
6-Month Intensive Period (182 Days)
Lost to Follow-up
|
0
|
1
|
|
6-Month Intensive Period (182 Days)
Met Protocol Withdrawal Criteria
|
2
|
1
|
|
6-Month Intensive Period (182 Days)
Physician Decision
|
2
|
3
|
|
6-Month Intensive Period (182 Days)
Withdrawal by Subject
|
13
|
7
|
|
Continuation Period
Adverse Event
|
13
|
5
|
|
Continuation Period
Lost to Follow-up
|
2
|
0
|
|
Continuation Period
Met Protocol Withdrawal Criteria
|
1
|
1
|
|
Continuation Period
Physician Decision
|
5
|
4
|
|
Continuation Period
Withdrawal by Subject
|
13
|
4
|
Baseline Characteristics
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
Baseline characteristics by cohort
| Measure |
Delamanid + OBR
n=341 Participants
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Placebo + OBR
n=170 Participants
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: The modified intent-to-treat (MITT) sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
SCC at 6 months was determined by the observation of a sputum specimen negative for growth of mycobacterium tuberculosis (MTB) using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the statistical analysis plan (SAP) was used to define a single representative result. Time to SCC was then defined as the interval between the date of first dose of IMP and the date of first of 2 consecutive negative single representative time points that were at least 25 days apart. The median time in days to SCC up to Month 6 is presented.
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System
|
51 Days
Interval 43.0 to 57.0
|
57 Days
Interval 56.0 to 64.0
|
SECONDARY outcome
Timeframe: Month 2 and Month 6Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
SCC was evaluated at 2 and 6 months (6-month Intensive Period) using MGIT. SCC at 2 months was defined to occur at the date of collection of the first sputum specimen with mycobacterial culture negative for growth of MTB using MGIT culture, followed by at least 1 confirmatory negative MGIT culture result at least 25 days after the first negative specimen and not followed by any sputum specimens positive for growth in the MGIT culture at any point up to 3 months (Week 12). SCC at 6 months was determined by the observation of a sputum specimen negative for growth of MTB using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the SAP was used to define a single representative result.
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Proportion of Participants With SCC At 2 And 6 Months Using MGIT
At Month 2
|
132 Participants
|
54 Participants
|
|
Proportion of Participants With SCC At 2 And 6 Months Using MGIT
At Month 6
|
198 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Month 18, Month 24, and Month 30Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
Sustained SCC was defined as SCC achieved by Month 6 and not followed by a confirmed positive thereafter, where confirmed positive was defined as 2 or more observed positive single representative culture results, not taking into account indeterminate, missing, or contaminated results. Sustained SCC was analyzed at Month 18 to 30 using MGIT.
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT
At 18 months
|
180 Participants
|
83 Participants
|
|
Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT
At 24 months
|
178 Participants
|
82 Participants
|
|
Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT
At 30 months
|
173 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Month 24Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
Final treatment outcomes were assessed by the Principal Investigator (PI) at the end of treatment with OBR (24 months post randomization) according to the 2008 World Health Organization (WHO) outcome definitions for treating participants with multidrug-resistant tuberculosis (MDR TB). Frequency counts and percentage of participants achieving favorable and unfavorable outcomes were provided by treatment group. Participants who had non-missing Principal Investigator assessed treatment outcomes at the end of treatment with OBR were included in the analysis.
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR
Unfavorable outcome
|
42 Participants
|
16 Participants
|
|
Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR
Favorable outcome
|
182 Participants
|
85 Participants
|
|
Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR
Missing PI Assessments
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 30Population: The intent-to-treat (ITT) sample comprised all randomized participants.
Acquired resistance was defined as a post-baseline resistant result at any time point after a Baseline susceptible result. The overall resistance to delamanid during the trial was assessed.
Outcome measures
| Measure |
Delamanid + OBR
n=341 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=170 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Number of Participants Who Developed Resistance To Delamanid
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, up to Month 6Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both, who had both a baseline and at least one post baseline TTD value.
The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture. The AUC of the change from Baseline for TTD in days (from Baseline to Month 6) summarizes the overall participant response for the treatment period. The change from Baseline in original time to detection of MGIT positive signal, in days, up to 6 months was performed using AUC in MGIT. The Baseline was defined as the average of Day -1 and Day 1 values if cultures on both days were positive; if only 1 culture was positive, the value for TTD for the positive culture was used as the Baseline. The TTD is Time to Detection measured by day, so the unit of AUC of change from baseline in TTD is day\*day. Since "Mean AUC" is reported, which is actually "Time Averaged AUC," the AUC was divided by the duration of the observation, and thus the unit of the Mean AUC is day.
Outcome measures
| Measure |
Delamanid + OBR
n=221 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=98 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Mean (Time Averaged) Area Under The Curve (AUC) Of Change From Baseline In Time To Detection (TTD) To Month 6 Using MGIT
|
21.9 days
Standard Deviation 9.44
|
23.3 days
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18)Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture during the routine 42-day incubation period. TTD analysis was based only on the corresponding qualitative sputum results of pure positive and pure negative cultures in days and hours of the initial positive signal for a culture from the MGIT printout. Mean change is reported for Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18).
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Mean Change From Baseline In TTD Using The MGIT System
At Baseline
|
16.7 days
Standard Deviation 7.9
|
15.4 days
Standard Deviation 7.7
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Week 1
|
20.8 days
Standard Deviation 10.3
|
19.9 days
Standard Deviation 11.1
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Week 1
|
4.3 days
Standard Deviation 7.9
|
4.8 days
Standard Deviation 7.8
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Week 2
|
24.6 days
Standard Deviation 11.5
|
23.1 days
Standard Deviation 11.4
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Week 2
|
7.7 days
Standard Deviation 8.9
|
7.5 days
Standard Deviation 7.8
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Week 3
|
28.4 days
Standard Deviation 11.8
|
25.5 days
Standard Deviation 12.4
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Week 3
|
11.6 days
Standard Deviation 9.8
|
10.4 days
Standard Deviation 9.6
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Week 24
|
40.4 days
Standard Deviation 6.6
|
41.3 days
Standard Deviation 3.9
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Week 24
|
23.4 days
Standard Deviation 10.2
|
25.5 days
Standard Deviation 8.3
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Week 26
|
40.6 days
Standard Deviation 5.9
|
40.5 days
Standard Deviation 5.5
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Week 26
|
23.8 days
Standard Deviation 9.5
|
24.6 days
Standard Deviation 9.4
|
|
Mean Change From Baseline In TTD Using The MGIT System
At Last Visit
|
39.4 days
Standard Deviation 8.4
|
40.3 days
Standard Deviation 6.3
|
|
Mean Change From Baseline In TTD Using The MGIT System
Change from Baseline at Last Visit
|
22.7 days
Standard Deviation 10.7
|
24.9 days
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Month 30Population: The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
Treatment success was defined as achieving SCC by 6 months using MGIT, completing the trial out to 30 months with sustained SCC and alive at the last contact for follow-up. All other participants were treatment failures who failed to achieve SCC by Month 6, achieved SCC but have a confirmed positive, early terminate from the trial prior to the Month 30 visit but are alive at the last contact for follow-up, lost to follow-up and vital status unknown and death.
Outcome measures
| Measure |
Delamanid + OBR
n=226 Participants
In the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
|
Placebo + OBR
n=101 Participants
In the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
|
|---|---|---|
|
Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT
Success
|
173 Participants
|
78 Participants
|
|
Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT
Failure
|
53 Participants
|
23 Participants
|
Adverse Events
Delamanid + OBR
Serious events: 89 serious events
Other events: 335 other events
Deaths: 18 deaths
Placebo + OBR
Serious events: 47 serious events
Other events: 165 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Delamanid + OBR
n=341 participants at risk
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Placebo + OBR
n=170 participants at risk
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cardiac failure acute
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Cor pulmonale
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Metabolic cardiomyopathy
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Ear and labyrinth disorders
Deafness
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
1.2%
4/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
2.4%
4/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Endocrine disorders
Goitre
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Endocrine disorders
Hypothyroidism
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Eye disorders
Glaucoma
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Gastritis
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Asthenia
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Hypothermia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Jaundice
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Appendicitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Appendicitis perforated
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Cellulitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Empyema
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Gastroenteritis
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Lung abscess
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Osteomyelitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Peritonitis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pneumonia
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pneumonia viral
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pulmonary tuberculoma
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Sepsis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Tuberculoma of central nervous system
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Tuberculosis
|
3.2%
11/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.8%
3/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Viral infection
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Investigations
Aspartate aminotransferase increased
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.8%
6/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Investigations
Transaminases increased
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.8%
3/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
9/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.8%
3/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Cerebral infarction
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Seizure
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Tremor
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Acute psychosis
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Alcohol abuse
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Anxiety
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Anxiety disorder
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Completed suicide
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Confusional state
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Delirium tremens
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Depression
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Major depression
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Psychotic disorder
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Reactive psychosis
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Suicidal ideation
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Suicide attempt
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
2.9%
5/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Renal and urinary disorders
Renal impairment
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.59%
2/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haematoma
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
1.2%
2/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Vascular disorders
Deep vein thrombosis
|
0.88%
3/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Vascular disorders
Hypertension
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.00%
0/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Vascular disorders
Hypotension
|
0.29%
1/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
0.59%
1/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
Other adverse events
| Measure |
Delamanid + OBR
n=341 participants at risk
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive 100 mg delamanid orally BID (morning and evening) + OBR for 2 months, followed by 200 mg delamanid QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
Placebo + OBR
n=170 participants at risk
In the first period of this study, known as the 6-month Intensive Period, participants were randomized to receive placebo orally BID (morning and evening) + OBR for 2 months followed by placebo QD (every morning) + OBR for 4 months.
Following the 6-month Intensive Period, participants entered the second period of the study, known as the Continuation Period, wherein OBR was administered alone for 12 to 18 months.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.8%
71/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
25.3%
43/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Pharyngitis
|
9.4%
32/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
13.5%
23/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
22/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.9%
10/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Rhinitis
|
3.8%
13/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.9%
10/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.4%
49/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
12.4%
21/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
36/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.8%
15/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
17/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.3%
9/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Cardiac disorders
Palpitations
|
5.6%
19/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
7.1%
12/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
4.4%
15/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.3%
9/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Ear and labyrinth disorders
Hypoacusis
|
4.4%
15/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.8%
15/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Ear and labyrinth disorders
Tinnitus
|
20.8%
71/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
21.2%
36/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Eye disorders
Vision blurred
|
3.8%
13/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.9%
10/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
33/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
12.4%
21/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
35/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
16.5%
28/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Constipation
|
3.5%
12/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
7.6%
13/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
62/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
19.4%
33/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
33/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.2%
14/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Gastritis
|
22.3%
76/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
15.9%
27/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
19/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
6.5%
11/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Nausea
|
27.9%
95/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
32.9%
56/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Toothache
|
8.5%
29/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
10.0%
17/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Gastrointestinal disorders
Vomiting
|
27.0%
92/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
22.9%
39/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Asthenia
|
7.9%
27/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.9%
10/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Chest pain
|
6.5%
22/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
4.7%
8/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
General disorders
Injection site pain
|
7.0%
24/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
11.8%
20/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
5.9%
20/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
6.5%
11/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Bronchitis
|
5.6%
19/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
7.6%
13/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Infections and infestations
Influenza
|
6.2%
21/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
3.5%
6/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.6%
26/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.3%
9/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
34/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
12.9%
22/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.5%
53/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
17.1%
29/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
20/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
4.1%
7/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.0%
116/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
38.2%
65/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
44/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
18.2%
31/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
21/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.9%
10/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
31/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.2%
14/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
24/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
9.4%
16/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Dizziness
|
15.0%
51/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
13.5%
23/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Headache
|
30.5%
104/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
22.9%
39/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.2%
28/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
10.6%
18/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Nervous system disorders
Tremor
|
6.2%
21/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
2.9%
5/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Adjustment disorder
|
2.3%
8/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.3%
9/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Alcohol abuse
|
4.1%
14/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.8%
15/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Anxiety
|
8.2%
28/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
12.4%
21/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Depression
|
7.6%
26/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
11.2%
19/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Psychiatric disorders
Insomnia
|
25.5%
87/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
27.1%
46/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Renal and urinary disorders
Proteinuria
|
5.3%
18/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
4.1%
7/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
28/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
8.2%
14/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
27/341 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
5.3%
9/170 • Adverse events were collected throughout the study (30 months)
Adverse events were collected for randomized participants who received any amount of study drug, regardless of any protocol deviation or violation.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: +1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60