Trial Outcomes & Findings for OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17) (NCT NCT02097121)
NCT ID: NCT02097121
Last Updated: 2022-12-28
Results Overview
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Results posted on
2022-12-28
Participant Flow
Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment arms. Randomization was stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day bladder diary collection period).
Participant milestones
| Measure |
Botox 25 U
Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
Botox 50 U
Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
Botox 100 U
Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
19
|
|
Overall Study
Received Any Treatment
|
19
|
17
|
19
|
|
Overall Study
Actual Treatment Received in Cycle 1
|
18
|
17
|
20
|
|
Overall Study
Actual Treatment Received in Cycle 2
|
1
|
17
|
28
|
|
Overall Study
Actual Treatment Received in Cycle 3
|
2
|
7
|
13
|
|
Overall Study
Actual Treatment Received in Cycle 4
|
0
|
1
|
3
|
|
Overall Study
COMPLETED
|
12
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
10
|
Reasons for withdrawal
| Measure |
Botox 25 U
Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
Botox 50 U
Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
Botox 100 U
Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
|
|---|---|---|---|
|
Overall Study
Other, not specified
|
4
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
Baseline Characteristics
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Baseline characteristics by cohort
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 1.49 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.86 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
14.0 years
STANDARD_DEVIATION 1.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Daily Frequency of Daytime Urinary Incontinence Episodes
|
5.29 number of episodes
STANDARD_DEVIATION 3.447 • n=5 Participants
|
3.54 number of episodes
STANDARD_DEVIATION 2.696 • n=7 Participants
|
3.64 number of episodes
STANDARD_DEVIATION 2.951 • n=5 Participants
|
4.15 number of episodes
STANDARD_DEVIATION 3.100 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
|
-1.37 urinary incontinence episodes per day
Standard Error 0.801
|
-0.97 urinary incontinence episodes per day
Standard Error 0.811
|
-2.35 urinary incontinence episodes per day
Standard Error 0.746
|
SECONDARY outcome
Timeframe: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
Micturition was defined as toilet voids recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
|
-1.84 micturition episodes per day
Standard Error 1.027
|
0.31 micturition episodes per day
Standard Error 1.014
|
-1.02 micturition episodes per day
Standard Error 0.983
|
SECONDARY outcome
Timeframe: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
Participants recorded daytime urgency episodes in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
|
-1.85 urgency episodes per day
Standard Error 1.014
|
-1.78 urgency episodes per day
Standard Error 0.998
|
-2.18 urgency episodes per day
Standard Error 0.945
|
SECONDARY outcome
Timeframe: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Percentage of Participants With Night Time Urinary Incontinence
Baseline-0 nights
|
22.2 percentage of participants
|
52.9 percentage of participants
|
35.0 percentage of participants
|
|
Percentage of Participants With Night Time Urinary Incontinence
Baseline-1 night
|
27.8 percentage of participants
|
11.8 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants With Night Time Urinary Incontinence
Baseline-2 nights
|
50.0 percentage of participants
|
35.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Night Time Urinary Incontinence
Week 12-0 nights
|
50.0 percentage of participants
|
76.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Night Time Urinary Incontinence
Week 12-1 night
|
22.2 percentage of participants
|
5.9 percentage of participants
|
15.0 percentage of participants
|
|
Percentage of Participants With Night Time Urinary Incontinence
Week 12-2 nights
|
27.8 percentage of participants
|
17.6 percentage of participants
|
35.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
|
-9.17 mL
Standard Error 15.924
|
24.94 mL
Standard Error 17.047
|
26.16 mL
Standard Error 15.900
|
SECONDARY outcome
Timeframe: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
|
-6.96 units on a scale
Standard Error 2.841
|
-5.11 units on a scale
Standard Error 3.243
|
-8.28 units on a scale
Standard Error 2.979
|
SECONDARY outcome
Timeframe: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
|
-0.06 units on a scale
Standard Error 0.238
|
-0.37 units on a scale
Standard Error 0.273
|
-0.09 units on a scale
Standard Error 0.251
|
SECONDARY outcome
Timeframe: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
|
-0.54 units on a scale
Standard Error 0.209
|
-0.15 units on a scale
Standard Error 0.238
|
-0.24 units on a scale
Standard Error 0.220
|
SECONDARY outcome
Timeframe: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1Population: Participants with analysis values at both baseline and Week 12
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=20 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
|
-0.39 units on a scale
Standard Error 0.193
|
-0.24 units on a scale
Standard Error 0.218
|
-0.27 units on a scale
Standard Error 0.201
|
SECONDARY outcome
Timeframe: At Week 12 in Treatment Cycle 1Population: Participants with non-missing values at Week 12
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=17 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=19 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
|
52.9 percentage of participants
Interval 27.81 to 77.02
|
70.6 percentage of participants
Interval 44.04 to 89.69
|
68.4 percentage of participants
Interval 43.45 to 87.42
|
SECONDARY outcome
Timeframe: From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatmentPopulation: BOTOX-treated participants who requested retreatment
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=17 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=14 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=17 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Time to Participant's First Request for Retreatment
|
16.6 weeks
Interval 12.71 to 25.29
|
17.6 weeks
Interval 11.29 to 38.57
|
21.3 weeks
Interval 12.86 to 30.14
|
SECONDARY outcome
Timeframe: From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatmentPopulation: BOTOX-treated participants who qualified for retreatment
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=16 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=14 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=17 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Time to Participant's Qualification for Retreatment
|
22.5 weeks
Interval 13.57 to 36.29
|
18.1 weeks
Interval 12.29 to 52.57
|
24.1 weeks
Interval 12.86 to 41.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the first dose of study drug until the last dose, up to 147 weeksPopulation: All participants enrolled into the study who received at least 1 BOTOX treatment
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
BOTOX 25 U (BOTOX-Treated Population)
n=18 Participants
Participants received 25 U BOTOX in Treatment Cycle 1
|
BOTOX 50 U (BOTOX-Treated Population)
n=17 Participants
Participants received 50 U BOTOX in Treatment Cycle 1
|
BOTOX 100 U (BOTOX-Treated Population)
n=28 Participants
Participants received 100 U BOTOX in Treatment Cycle 1
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Cycle 1
|
13 Participants
|
12 Participants
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Cycle 2
|
1 Participants
|
13 Participants
|
18 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Cycle 3
|
1 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Cycle 4
|
—
|
1 Participants
|
1 Participants
|
Adverse Events
25 U BOTOX All
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
50 U BOTOX All
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
100 U BOTOX All
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
25 U BOTOX Cycle 1
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
50 U BOTOX Cycle 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
100 U BOTOX Cycle 1
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
All BOTOX Cycle 1
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
25 U BOTOX Cycle 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 U BOTOX Cycle 2
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
100 U BOTOX Cycle 2
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
All BOTOX Cycle 2
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
25 U BOTOX Cycle 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 U BOTOX Cycle 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 U BOTOX Cycle 3
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
All BOTOX Cycle 3
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
25 U BOTOX Cycle 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 U BOTOX Cycle 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 U BOTOX Cycle 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
All BOTOX Cycle 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25 U BOTOX All
n=18 participants at risk
All participants who received 25 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX All
n=29 participants at risk
All participants who received 50 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX All
n=33 participants at risk
All participants who received 100 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
25 U BOTOX Cycle 1
n=18 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 1
n=17 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 1
n=20 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 1
n=55 participants at risk
All BOTOX-treated participants in Treatment Cycle 1
|
25 U BOTOX Cycle 2
n=1 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 2
n=17 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 2
n=28 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 2
n=46 participants at risk
All BOTOX-treated participants in Treatment Cycle 2
|
25 U BOTOX Cycle 3
n=2 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 3
n=7 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 3
n=13 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 3
n=22 participants at risk
All BOTOX-treated participants in Treatment Cycle 3
|
25 U BOTOX Cycle 4
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 4
n=1 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 4
n=3 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 4
n=4 participants at risk
All BOTOX-treated participants in Treatment Cycle 4
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
MALAISE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Social circumstances
SOCIAL PROBLEM
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Vascular disorders
PALLOR
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
Other adverse events
| Measure |
25 U BOTOX All
n=18 participants at risk
All participants who received 25 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX All
n=29 participants at risk
All participants who received 50 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX All
n=33 participants at risk
All participants who received 100 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
25 U BOTOX Cycle 1
n=18 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 1
n=17 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 1
n=20 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 1
n=55 participants at risk
All BOTOX-treated participants in Treatment Cycle 1
|
25 U BOTOX Cycle 2
n=1 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 2
n=17 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 2
n=28 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 2
n=46 participants at risk
All BOTOX-treated participants in Treatment Cycle 2
|
25 U BOTOX Cycle 3
n=2 participants at risk
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 3
n=7 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 3
n=13 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 3
n=22 participants at risk
All BOTOX-treated participants in Treatment Cycle 3
|
25 U BOTOX Cycle 4
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
50 U BOTOX Cycle 4
n=1 participants at risk
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
100 U BOTOX Cycle 4
n=3 participants at risk
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
|
All BOTOX Cycle 4
n=4 participants at risk
All BOTOX-treated participants in Treatment Cycle 4
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Cardiac disorders
TACHYCARDIA
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Ear and labyrinth disorders
HYPERACUSIS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Ear and labyrinth disorders
MISOPHONIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.5%
3/55 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
NAUSEA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.3%
3/29 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
17.6%
3/17 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
CHRONIC FATIGUE SYNDROME
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
FATIGUE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
ILLNESS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
MALAISE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
33.3%
1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
General disorders
PYREXIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
BACTERIURIA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.8%
2/17 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.7%
3/28 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
18.2%
6/33 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.8%
2/17 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
15.0%
3/20 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.9%
6/55 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
4/28 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
8.7%
4/46 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
PHARYNGITIS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
SINUSITIS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.8%
2/17 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.1%
2/18 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
20.7%
6/29 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
18.2%
6/33 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.1%
2/18 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.8%
2/17 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.0%
2/20 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.9%
6/55 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
23.5%
4/17 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
32.1%
9/28 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
28.3%
13/46 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
28.6%
2/7 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
30.8%
4/13 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
27.3%
6/22 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
ANIMAL SCRATCH
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
EPSTEIN-BARR VIRUS TEST POSITIVE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
FALL
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCOMFORT
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
BLOOD URINE PRESENT
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
CRYSTAL URINE PRESENT
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
CYTOMEGALOVIRUS TEST POSITIVE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
RED BLOOD CELLS URINE POSITIVE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
RESIDUAL URINE VOLUME
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
33.3%
1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Investigations
URINE LEUKOCYTE ESTERASE POSITIVE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
100.0%
1/1 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Metabolism and nutrition disorders
ABNORMAL WEIGHT GAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
33.3%
1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
SACRAL PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
50.0%
1/2 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
12.1%
4/33 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.8%
2/17 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
15.0%
3/20 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
9.1%
5/55 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.7%
3/28 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.5%
3/46 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
23.1%
3/13 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
13.6%
3/22 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Psychiatric disorders
ANOREXIA NERVOSA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Psychiatric disorders
ANXIETY
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
BLADDER DISCOMFORT
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
DYSURIA
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
17.2%
5/29 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
9.1%
3/33 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
9.1%
5/55 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
23.5%
4/17 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
13.0%
6/46 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
HAEMATURIA
|
11.1%
2/18 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.1%
2/18 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.9%
2/29 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
POLLAKIURIA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
URETHRAL PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
9.1%
2/22 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
GENITAL PAIN
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
HAEMORRHAGIC OVARIAN CYST
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.1%
2/28 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
14.3%
1/7 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
OEDEMA GENITAL
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DISCOMFORT
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Vascular disorders
HAEMATOMA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
1/28 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
11.1%
2/18 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
6.1%
2/33 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.3%
4/55 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
7.7%
1/13 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
4.5%
1/22 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
NAIL BED INFLAMMATION
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/55 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/29 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.0%
1/33 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.6%
1/18 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.6%
2/55 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
|
Vascular disorders
RAYNAUD'S PHENOMENON
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
3.4%
1/29 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/33 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/18 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
5.9%
1/17 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
1.8%
1/55 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/17 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/28 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/46 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/7 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/13 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/22 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
—
0/0 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/1 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/3 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER