Trial Outcomes & Findings for A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB (NCT NCT02333799)
NCT ID: NCT02333799
Last Updated: 2025-09-08
Results Overview
Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative. Bacteriologic relapse: During the follow-up period, failure to maintain culture conversion to negative status in culture, with culture conversion to positive status with a Mycobacterium tuberculosis (M.tb.) strain that is genetically identical to the infecting strain at baseline. Clinical failure: A change from protocol-specified tuberculosis (TB) treatment due to treatment failure, retreatment for TB during follow up, or TB-related death. Note: Culture conversion requires at least 2 consecutive culture negative/positive samples at least 7 days apart. Participants who are documented at a visit as unable to produce sputum and who are clinically considered to be responding well to treatment will be considered to be culture negative at that visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
6 Months post End of Treatment
Results posted on
2025-09-08
Participant Flow
Screening Phase: 143 participants were screened to determine eligibility to participate in the study using inclusion and exclusion criteria within 9 days of scheduled day 1 treatment dosing. 34 participants did not meet treatment criteria and were excluded from further study participation. 109 participants were enrolled in the study and began the treatment phase of the study.
Participant milestones
| Measure |
Bedaquiline + PA-824 + Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|
|
Treatment Period
STARTED
|
109
|
|
Treatment Period
COMPLETED
|
102
|
|
Treatment Period
NOT COMPLETED
|
7
|
|
6 Month Follow Up Period
STARTED
|
102
|
|
6 Month Follow Up Period
COMPLETED
|
100
|
|
6 Month Follow Up Period
NOT COMPLETED
|
2
|
|
7 to 24 Month Follow Up Period
STARTED
|
100
|
|
7 to 24 Month Follow Up Period
COMPLETED
|
98
|
|
7 to 24 Month Follow Up Period
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bedaquiline + PA-824 + Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|
|
Treatment Period
Withdrawal by Subject
|
1
|
|
Treatment Period
Death
|
6
|
|
6 Month Follow Up Period
Physician Decision
|
1
|
|
6 Month Follow Up Period
Death
|
1
|
|
7 to 24 Month Follow Up Period
Lost to Follow-up
|
1
|
|
7 to 24 Month Follow Up Period
Physician Decision
|
1
|
Baseline Characteristics
total number with height recorded
Baseline characteristics by cohort
| Measure |
Bedaquiline + PA-824 + Linezolid
n=109 Participants
bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 1200mg once daily .
Bedaquiline: 100mg tablets
PA-824: 200mg tablets
Linezolid: Scored 600mg tablets
|
|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 10.12 • n=109 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=109 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=109 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=109 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=109 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=109 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=109 Participants
|
|
Race (NIH/OMB)
More than one race
|
25 Participants
n=109 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=109 Participants
|
|
Height (cm)
|
165.78 cm
STANDARD_DEVIATION 10.408 • n=108 Participants • total number with height recorded
|
|
Weight (kg)
|
56.95 kg
STANDARD_DEVIATION 15.034 • n=109 Participants
|
|
BMI (kg/m^2)
|
20.60 kg/m^2
STANDARD_DEVIATION 5.046 • n=109 Participants
|
|
CD4 Count (cells/uL)
|
394.0 cells/uL
STANDARD_DEVIATION 212.00 • n=51 Participants • CD4 count for HIV positive patient (with a CD4 count available)
|
|
Karnofsky Score (%)
100 (Normal, no complaints)
|
9 Participants
n=109 Participants
|
|
Karnofsky Score (%)
90
|
50 Participants
n=109 Participants
|
|
Karnofsky Score (%)
80
|
29 Participants
n=109 Participants
|
|
Karnofsky Score (%)
70
|
19 Participants
n=109 Participants
|
|
Karnofsky Score (%)
60
|
2 Participants
n=109 Participants
|
|
Karnofsky Score (%)
50
|
0 Participants
n=109 Participants
|
|
Karnofsky Score (%)
40
|
0 Participants
n=109 Participants
|
|
Karnofsky Score (%)
30
|
0 Participants
n=109 Participants
|
|
Karnofsky Score (%)
20
|
0 Participants
n=109 Participants
|
|
Karnofsky Score (%)
10
|
0 Participants
n=109 Participants
|
|
Karnofsky Score (%)
0 (Dead)
|
0 Participants
n=109 Participants
|
PRIMARY outcome
Timeframe: 6 Months post End of TreatmentPopulation: Participants deemed unassessable were excluded from the Modified Intent to Treat (MITT) population as per the analysis plan.
Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative. Bacteriologic relapse: During the follow-up period, failure to maintain culture conversion to negative status in culture, with culture conversion to positive status with a Mycobacterium tuberculosis (M.tb.) strain that is genetically identical to the infecting strain at baseline. Clinical failure: A change from protocol-specified tuberculosis (TB) treatment due to treatment failure, retreatment for TB during follow up, or TB-related death. Note: Culture conversion requires at least 2 consecutive culture negative/positive samples at least 7 days apart. Participants who are documented at a visit as unable to produce sputum and who are clinically considered to be responding well to treatment will be considered to be culture negative at that visit.
Outcome measures
| Measure |
Total
n=107 Participants
Total Participants
|
XDR-TB
n=70 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=37 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment.
Favourable (treatment success)
|
98 Participants
|
63 Participants
|
35 Participants
|
—
|
—
|
|
Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After the End of Treatment.
Unfavourable (treatment failure)
|
9 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 Months post End of TreatmentPopulation: Participants deemed unassessable were excluded from the Modified Intent to Treat (MITT) population as per the analysis plan.
Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative. Bacteriologic relapse: During the follow-up period, failure to maintain culture conversion to negative status in culture, with culture conversion to positive status with a Mycobacterium tuberculosis (M.tb.) strain that is genetically identical to the infecting strain at baseline. Clinical failure: A change from protocol-specified TB treatment due to treatment failure, retreatment for TB during follow up, or TB-related death. Note: Culture conversion requires at least 2 consecutive culture negative/positive samples at least 7 days apart. Participants who are documented at a visit as unable to produce sputum and who are clinically considered to be responding well to treatment will be considered to be culture negative at that visit.
Outcome measures
| Measure |
Total
n=106 Participants
Total Participants
|
XDR-TB
n=69 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=37 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 24 Months After the End of Treatment.
Favourable (treatment success)
|
96 Participants
|
61 Participants
|
35 Participants
|
—
|
—
|
|
Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 24 Months After the End of Treatment.
Unfavourable (treatment failure)
|
10 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through End of Treatment, approximately 6 to 9 months of treatmentPopulation: Participants deemed unassessable were excluded from the Modified Intent to Treat (MITT) population as per the analysis plan.
Median time (in weeks) to culture negative status (first of 2 negative cultures without an intervening positive culture), MITT analysis.
Outcome measures
| Measure |
Total
n=88 Participants
Total Participants
|
XDR-TB
n=59 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=29 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Time to Sputum Culture Conversion to Negative Status Through the Treatment Period
|
6 Weeks
Interval 4.1 to 8.1
|
6 Weeks
Interval 4.1 to 8.3
|
6 Weeks
Interval 4.0 to 8.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 6, 8, 12, 16, 26, 39Population: Participants deemed unassessable were excluded from the Modified Intent to Treat (MITT) population as per the analysis plan.
Proportion of participants with sputum culture conversion to negative status for those positive at baseline at 4, 6, 8, 12, 16, and End of Treatment (26 or 39 weeks)
Outcome measures
| Measure |
Total
n=90 Participants
Total Participants
|
XDR-TB
n=60 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=30 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 4 · Negative
|
37 Participants
|
25 Participants
|
12 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 4 · Positive
|
53 Participants
|
35 Participants
|
18 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 4 · Died
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 6 · Negative
|
57 Participants
|
37 Participants
|
20 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 6 · Positive
|
32 Participants
|
22 Participants
|
10 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 6 · Died
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 8 · Negative
|
71 Participants
|
46 Participants
|
25 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 8 · Positive
|
15 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 8 · Died
|
4 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 12 · Negative
|
82 Participants
|
53 Participants
|
29 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 12 · Positive
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 12 · Died
|
5 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 16 · Negative
|
83 Participants
|
55 Participants
|
28 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 16 · Positive
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
Week 16 · Died
|
6 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
End of Treatment · Negative
|
84 Participants
|
55 Participants
|
29 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
End of Treatment · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Proportion of Participants With Sputum Culture Conversion to Negative Status
End of Treatment · Died
|
6 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 14 days post-End of TreatmentPopulation: Population analyzed contains all participants who received at least 1 dose of study treatment
Treatment-emergent adverse events (TEAEs): adverse events which started or worsened on or after the first trial drug administration up to and including 14 days after the last trial drug administration. Grade I, II, III, IV TEAEs: DMID grade is indicated as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening). TEAEs of special interest based on Section 7.3 of the protocol. Liver-related adverse events: any adverse event with a High Level Group Term of HEPATIC AND BILIARY NEOPLASMS BENIGN, HEPATIC AND HEPATOBILIARY DISORDERS, HEPATOBILIARY DISORDERS CONGENITAL, HEPATOBILIARY NEOPLASMS MALIGNANT AND UNSPECIFIED, HEPATOBILIARY INVESTIGATIONS or HEPATOBILIARY THERAPEUTIC PROCEDURES.
Outcome measures
| Measure |
Total
n=53 Participants
Total Participants
|
XDR-TB
n=56 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=44 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
n=65 Participants
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
n=109 Participants
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
658 events
|
633 events
|
491 events
|
800 events
|
1291 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE Leading To Death
|
5 events
|
5 events
|
6 events
|
4 events
|
10 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE (Including Death)
|
16 events
|
20 events
|
24 events
|
12 events
|
36 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE Leading To Early Trial Withdrawal
|
5 events
|
6 events
|
7 events
|
4 events
|
11 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE Leading To Discontinuation Of One Or All Drugs in the Trial Regimen (Per Investigator)
|
16 events
|
23 events
|
19 events
|
20 events
|
39 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE Leading To Interruption Of Trial Drug
|
40 events
|
41 events
|
46 events
|
35 events
|
81 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Drug-Related TEAE
|
387 events
|
319 events
|
298 events
|
408 events
|
706 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Serious Drug-Related TEAE
|
5 events
|
7 events
|
9 events
|
3 events
|
12 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE of Special Interest
|
157 events
|
158 events
|
132 events
|
183 events
|
315 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Liver-Related TEAE
|
27 events
|
38 events
|
27 events
|
38 events
|
65 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Drug-Related and Liver-Related TEAE
|
22 events
|
33 events
|
23 events
|
32 events
|
55 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Grade III and/or IV TEAE
|
49 events
|
77 events
|
65 events
|
61 events
|
126 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Serious Liver-Related TEAE
|
1 events
|
0 events
|
0 events
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: Day 1 to 14 days post-End of TreatmentPopulation: The Safety analysis population is defined as all participants who received at least 1 administration of trial treatment.
Treatment-emergent adverse events (TEAEs): Defined as adverse events which started or worsened on or after the first trial drug administration up to and including 14 days after the last trial drug administration. TEAEs of special interest: Identified by prespecified SMQ codes as confirmed by TB Alliance. Section 7.3 of the protocol specified the "Monitoring and Safety for Specific Toxicities" and are presented here as TEAEs of special interest. These specific toxicities of interest were based on nonclinical toxicology findings of concern for any of the 3 trial drugs, or from identified toxicities based on the IBs for pretomanid and bedaquiline, on the product label for linezolid and literature reports of linezolid long-term toxicity.
Outcome measures
| Measure |
Total
n=53 Participants
Total Participants
|
XDR-TB
n=56 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=44 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
n=65 Participants
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
n=109 Participants
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Liver-Related Investigations, Signs, and Symptoms
|
15 Participants
|
25 Participants
|
17 Participants
|
23 Participants
|
40 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Haematopoietic Cytopenias
|
22 Participants
|
30 Participants
|
25 Participants
|
27 Participants
|
52 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Haematopoietic Thrombocytopenia
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Drug-Related Hepatic Disorders - Comprehensive Search
|
16 Participants
|
26 Participants
|
19 Participants
|
23 Participants
|
42 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Cholestasis and Jaundice of Hepatic Origin
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Drug-Related Hepatic Disorders - Severe Events Only
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Hepatic Failure, Fibrosis and Cirrhosis and Other Liver Damage-Related Conditions
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Bradyarrhythmias (Incl. Conduction Defects and Disorders of Sinus Node Function)
|
2 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Disorders of Sinus Node Function
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Tachyarrhythmias (Incl. Supraventricular and Ventricular Tachyarrhythmias)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Supraventricular Tachyarrhythmias
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Lactic Acidosis
|
5 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Peripheral Neurpoathy
|
44 Participants
|
44 Participants
|
33 Participants
|
55 Participants
|
88 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Haematopoietic Erythropenia
|
16 Participants
|
24 Participants
|
20 Participants
|
20 Participants
|
40 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Haematopoietic Leukopenia
|
2 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
12 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Haematopoietic Cytopenias Affecting More Than One Type of Blood Cell
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Hepatic Disorders
|
16 Participants
|
26 Participants
|
19 Participants
|
23 Participants
|
42 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Optic Nerve Disorders
|
9 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
14 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Cardiac Arrhythmias
|
5 Participants
|
7 Participants
|
2 Participants
|
10 Participants
|
12 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Cardiac Arrhythmia Terms (Incl. Bradyarrhythmias and Tachyarrhythmias)
|
3 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Conduction Defects
|
2 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Arrhythmia-Related Investigations, Signs, and Symptoms
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Rhabdomyolysis/Myopathy
|
8 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
11 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Acute Pancreatitis
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) of Special Interest
Convulsions
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 14 days post-End of TreatmentPopulation: The Safety analysis population is defined as all participants who received at least 1 administration of trial treatment.
Treatment-emergent adverse events (TEAEs): Defined as adverse events which started or worsened on or after the first trial drug administration up to and including 14 days after the last trial drug administration. #: Indicates TEAEs of special interest. TEAEs of special interest: Identified by pre-specified SMQ codes as confirmed by TB Alliance. Adverse events in System Organ Class "NERVOUS SYSTEM DISORDERS" are presented into the table. Preferred term "PERIPHERAL NEUROPATHY" was a grouping of terms "PERIPHERAL SENSORY NEUROPATHY", "NEUROPATHY PERIPHERAL", "PARAESTHESIA", "HYPOAESTHESIA", "PERIPHERAL MOTOR NEUROPATHY", "BURNING SENSATION", "HYPOREFLEXIA" and "PERIPHERAL SENSORIMOTOR NEUROPATHY".
Outcome measures
| Measure |
Total
n=53 Participants
Total Participants
|
XDR-TB
n=56 Participants
Extensively Drug-Resistant Tuberculosis (XDR-TB) Population
|
TI/NR MDR-TB
n=44 Participants
Treatment-Intolerant/Nonresponsive Multidrug-Resistant Tuberculosis (TB) Population
|
1200 mg QD Linezolid
n=65 Participants
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (2 x linezolid 600 mg tablets once daily)
|
Total
n=109 Participants
Total Trial Population
Bedaquiline (Days 1 to 14): 400 mg once daily (4 x bedaquiline 100mg tablets); Bedaquiline (Weeks 3 to 26 or 39\*): 200 mg three days a week (2 x bedaquiline 100 mg tablets); plus Pretomanid: (Day 1 through weeks 26 or 39\*) 200 mg once daily (1 x pretomanid 200 mg tablet); plus Linezolid: (Day 1 through weeks 26 or 39\*) 1200 mg daily (1 x linezolid 600 mg tablet twice daily, later amended to 2 x linezolid 600 mg tablets once daily)
\*Note - participants received a minimum of 6 months (week 26) of trial treatment. If participants were culture positive or reverted to being culture positive between month 4 and month 6, and their clinical condition suggested they may have ongoing TB infection, the trial treatment could have been extended to 9 months (week 39).
|
|---|---|---|---|---|---|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
#Peripheral Neuropathy
|
68 events
|
56 events
|
51 events
|
73 events
|
124 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Headache
|
16 events
|
16 events
|
15 events
|
17 events
|
32 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Dizziness
|
3 events
|
2 events
|
1 events
|
4 events
|
5 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Dysgeusia
|
1 events
|
3 events
|
1 events
|
3 events
|
4 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Dizziness Postural
|
1 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Dystonia
|
1 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Taste Disorder
|
1 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Nervous System Disorders
|
94 events
|
83 events
|
75 events
|
102 events
|
177 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Chronic Inflammatory Demyelinating Polyradiculoneurpoathy
|
0 events
|
1 events
|
0 events
|
1 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
#Generalized Tonic-Clonic Seizure
|
1 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Migraine
|
0 events
|
1 events
|
1 events
|
0 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
#Optic Neuritis
|
1 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
#Seizure
|
0 events
|
1 events
|
1 events
|
0 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Sinus Headache
|
1 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
Tension Headache
|
0 events
|
1 events
|
0 events
|
1 events
|
1 events
|
|
Incidence of Nervous System Disorders - Peripheral Neuropathy Events Grouped
#Syncope
|
0 events
|
2 events
|
2 events
|
0 events
|
2 events
|
Adverse Events
Bedaquiline + PA-824 + 600mg BID Linezolid
Serious events: 13 serious events
Other events: 44 other events
Deaths: 5 deaths
Bedaquiline + PA-824 + 1200mg QD Linezolid
Serious events: 6 serious events
Other events: 65 other events
Deaths: 3 deaths
Total
Serious events: 19 serious events
Other events: 109 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Bedaquiline + PA-824 + 600mg BID Linezolid
n=44 participants at risk
bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 600mg twice daily .
Bedaquiline: 100mg tablets
PA-824: 200mg tablets
Linezolid: Scored 600mg tablets
|
Bedaquiline + PA-824 + 1200mg QD Linezolid
n=65 participants at risk
bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 1200mg once daily .
Bedaquiline: 100mg tablets
PA-824: 200mg tablets
Linezolid: Scored 600mg tablets
|
Total
n=109 participants at risk
Total Population
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
3/65 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
2.8%
3/109 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
2.8%
3/109 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.8%
2/109 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Disseminated Tuberculosis
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Tuberculoma of Central Nervous System
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Pancreatitis Haemorrhagic
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.8%
2/109 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Abnormal Loss of Weight
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Generalized Tonic-Clonic Seizure
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.8%
2/109 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax Spontaneous
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Psychiatric disorders
Depression Suicidal
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Psychiatric disorders
Generalized Anxiety Disorder
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Eye disorders
Optic Neuropaty
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.00%
0/65 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Transaminases Increased
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
0.92%
1/109 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
Other adverse events
| Measure |
Bedaquiline + PA-824 + 600mg BID Linezolid
n=44 participants at risk
bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 600mg twice daily .
Bedaquiline: 100mg tablets
PA-824: 200mg tablets
Linezolid: Scored 600mg tablets
|
Bedaquiline + PA-824 + 1200mg QD Linezolid
n=65 participants at risk
bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 1200mg once daily .
Bedaquiline: 100mg tablets
PA-824: 200mg tablets
Linezolid: Scored 600mg tablets
|
Total
n=109 participants at risk
Total Population
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.2%
19/44 • Number of events 20 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
30.8%
20/65 • Number of events 20 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
35.8%
39/109 • Number of events 40 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.8%
7/65 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
4/44 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
6.8%
3/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.7%
4/109 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
6/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.1%
11/109 • Number of events 11 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.4%
5/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.4%
7/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
6/44 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.1%
11/109 • Number of events 14 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
6/44 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
29.2%
19/65 • Number of events 22 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
22.9%
25/109 • Number of events 29 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
4/44 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.9%
18/44 • Number of events 27 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
32.3%
21/65 • Number of events 32 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
35.8%
39/109 • Number of events 59 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
16/44 • Number of events 24 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
32.3%
21/65 • Number of events 35 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
33.9%
37/109 • Number of events 59 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Influenza
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.4%
7/109 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
4/44 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
23.1%
15/65 • Number of events 23 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
17.4%
19/109 • Number of events 27 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
3/65 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
2/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
12.3%
8/65 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
10/109 • Number of events 12 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Amylase increased
|
11.4%
5/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
8.3%
9/109 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
12.3%
8/65 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
8.3%
9/109 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Blood urea increased
|
9.1%
4/44 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Gamma-glutamyltran sferase increased
|
13.6%
6/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
20.0%
13/65 • Number of events 13 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
17.4%
19/109 • Number of events 19 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Lipase increased
|
6.8%
3/44 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Investigations
Transaminases increased
|
20.5%
9/44 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.1%
11/109 • Number of events 12 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.8%
7/65 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
8.3%
9/109 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
8/44 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
23.1%
15/65 • Number of events 20 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
21.1%
23/109 • Number of events 30 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.4%
7/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.8%
3/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
12.3%
8/65 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.1%
11/109 • Number of events 11 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
6/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.8%
7/65 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
11.9%
13/109 • Number of events 15 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
6.8%
3/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
3/65 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.8%
7/65 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Headache
|
34.1%
15/44 • Number of events 15 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
21.5%
14/65 • Number of events 16 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
26.6%
29/109 • Number of events 31 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.5%
9/44 • Number of events 14 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
1.5%
1/65 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
10/109 • Number of events 15 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
52.3%
23/44 • Number of events 30 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
80.0%
52/65 • Number of events 60 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
68.8%
75/109 • Number of events 90 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Psychiatric disorders
Insomnia
|
6.8%
3/44 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
3/65 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
5.5%
6/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.7%
5/65 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 5 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/44 • Number of events 1 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.4%
7/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.7%
4/109 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
18.2%
8/44 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
12.8%
14/109 • Number of events 17 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
9.1%
4/44 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
20.0%
13/65 • Number of events 14 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
15.6%
17/109 • Number of events 18 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/44 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
6.2%
4/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.7%
4/109 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
21.5%
14/65 • Number of events 16 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
14.7%
16/109 • Number of events 18 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
36.4%
16/44 • Number of events 18 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
13.8%
9/65 • Number of events 10 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
22.9%
25/109 • Number of events 28 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
3/44 • Number of events 3 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
3.1%
2/65 • Number of events 4 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
4.6%
5/109 • Number of events 7 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
6/44 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
13.8%
9/65 • Number of events 13 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
13.8%
15/109 • Number of events 19 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.9%
7/44 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
10.8%
7/65 • Number of events 9 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
12.8%
14/109 • Number of events 18 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
|
Vascular disorders
Hypertension
|
4.5%
2/44 • Number of events 2 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
9.2%
6/65 • Number of events 6 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
7.3%
8/109 • Number of events 8 • Day 1 to 24 Months post-End of Treatment.
Adverse events (AEs) collected for all participants who received at least one dose of study treatment. Includes all AEs which started or worsened on or after the first trial drug administration through 14 days after administration. All-cause mortality reported for participants through 24 Months post-End of Treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place