Trial Outcomes & Findings for An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease (NCT NCT03467958)
NCT ID: NCT03467958
Last Updated: 2025-09-17
Results Overview
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
854 participants
Primary outcome timeframe
At weeks 48, 96, 144, 192, 240
Results posted on
2025-09-17
Participant Flow
Participant milestones
| Measure |
RPC01-3201/3202 Placebo
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
179
|
329
|
66
|
85
|
91
|
38
|
33
|
20
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
179
|
329
|
66
|
85
|
91
|
38
|
33
|
20
|
13
|
Reasons for withdrawal
| Measure |
RPC01-3201/3202 Placebo
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
20
|
32
|
5
|
3
|
3
|
3
|
6
|
5
|
0
|
|
Overall Study
Lack of Efficacy
|
59
|
120
|
6
|
9
|
8
|
9
|
11
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Other reasons
|
8
|
14
|
2
|
1
|
4
|
0
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
65
|
117
|
45
|
64
|
66
|
17
|
11
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
25
|
44
|
7
|
8
|
6
|
8
|
4
|
1
|
4
|
Baseline Characteristics
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
RPC01-3201/3202 Placebo
n=179 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 Participants
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
Total
n=854 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.93 Years
STANDARD_DEVIATION 13.147 • n=93 Participants
|
39.21 Years
STANDARD_DEVIATION 13.508 • n=4 Participants
|
40.80 Years
STANDARD_DEVIATION 13.988 • n=27 Participants
|
38.21 Years
STANDARD_DEVIATION 13.819 • n=483 Participants
|
41.98 Years
STANDARD_DEVIATION 13.116 • n=36 Participants
|
34.84 Years
STANDARD_DEVIATION 11.100 • n=10 Participants
|
38.06 Years
STANDARD_DEVIATION 12.686 • n=115 Participants
|
39.30 Years
STANDARD_DEVIATION 14.697 • n=40 Participants
|
44.00 Years
STANDARD_DEVIATION 10.368 • n=8 Participants
|
39.10 Years
STANDARD_DEVIATION 13.360 • n=62 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=93 Participants
|
151 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
48 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
388 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=93 Participants
|
178 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
43 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
466 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
35 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=93 Participants
|
309 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
802 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
17 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
70 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=93 Participants
|
274 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
82 Participants
n=36 Participants
|
34 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
19 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
739 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
35 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: At weeks 48, 96, 144, 192, 240Population: All treated participants
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
| Measure |
RPC01-3201/3202 Placebo
n=179 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 Participants
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission
Week 48
|
19.6 Percentage of participants
|
21.0 Percentage of participants
|
60.6 Percentage of participants
|
58.8 Percentage of participants
|
56.0 Percentage of participants
|
34.2 Percentage of participants
|
27.3 Percentage of participants
|
20.0 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants With Clinical Remission
Week 96
|
12.3 Percentage of participants
|
12.5 Percentage of participants
|
37.9 Percentage of participants
|
41.2 Percentage of participants
|
38.5 Percentage of participants
|
18.4 Percentage of participants
|
15.2 Percentage of participants
|
15.0 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants With Clinical Remission
Week 144
|
6.1 Percentage of participants
|
7.0 Percentage of participants
|
22.7 Percentage of participants
|
23.5 Percentage of participants
|
18.7 Percentage of participants
|
13.2 Percentage of participants
|
12.1 Percentage of participants
|
0 Percentage of participants
|
61.5 Percentage of participants
|
|
Percentage of Participants With Clinical Remission
Week 192
|
4.5 Percentage of participants
|
4.6 Percentage of participants
|
6.1 Percentage of participants
|
11.8 Percentage of participants
|
9.9 Percentage of participants
|
2.6 Percentage of participants
|
3.0 Percentage of participants
|
5.0 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants With Clinical Remission
Week 240
|
2.8 Percentage of participants
|
3.6 Percentage of participants
|
1.5 Percentage of participants
|
3.5 Percentage of participants
|
1.1 Percentage of participants
|
2.6 Percentage of participants
|
0 Percentage of participants
|
5.0 Percentage of participants
|
38.5 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)Population: All treated participants
A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
RPC01-3201/3202 Placebo
n=179 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 Participants
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE
|
140 Participants
|
247 Participants
|
42 Participants
|
63 Participants
|
52 Participants
|
26 Participants
|
22 Participants
|
14 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE
|
38 Participants
|
59 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation to study drug
|
30 Participants
|
43 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At weeks 48, 96, 144, 192, 240Population: All treated participants
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.
Outcome measures
| Measure |
RPC01-3201/3202 Placebo
n=179 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 Participants
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Week 144
|
5.6 Percentage of participants
|
7.3 Percentage of participants
|
21.2 Percentage of participants
|
24.7 Percentage of participants
|
14.3 Percentage of participants
|
13.2 Percentage of participants
|
12.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Week 48
|
16.2 Percentage of participants
|
21.3 Percentage of participants
|
53.0 Percentage of participants
|
52.9 Percentage of participants
|
45.1 Percentage of participants
|
34.2 Percentage of participants
|
18.2 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Week 96
|
11.2 Percentage of participants
|
11.6 Percentage of participants
|
37.9 Percentage of participants
|
36.5 Percentage of participants
|
36.3 Percentage of participants
|
18.4 Percentage of participants
|
12.1 Percentage of participants
|
15.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Week 192
|
2.8 Percentage of participants
|
4.9 Percentage of participants
|
6.1 Percentage of participants
|
10.6 Percentage of participants
|
7.7 Percentage of participants
|
2.6 Percentage of participants
|
3.0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Week 240
|
3.4 Percentage of participants
|
3.0 Percentage of participants
|
1.5 Percentage of participants
|
1.2 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At weeks 48, 96, 144, 192, 240Population: All treated participants
Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
| Measure |
RPC01-3201/3202 Placebo
n=179 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 Participants
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 Participants
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 Participants
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 Participants
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response
Week 48
|
26.8 Percentage of participants
|
29.2 Percentage of participants
|
62.1 Percentage of participants
|
64.7 Percentage of participants
|
61.5 Percentage of participants
|
36.8 Percentage of participants
|
30.3 Percentage of participants
|
20.0 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants With Clinical Response
Week 96
|
15.1 Percentage of participants
|
17.3 Percentage of participants
|
43.9 Percentage of participants
|
44.7 Percentage of participants
|
45.1 Percentage of participants
|
18.4 Percentage of participants
|
15.2 Percentage of participants
|
15.0 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Participants With Clinical Response
Week 144
|
8.9 Percentage of participants
|
9.4 Percentage of participants
|
22.7 Percentage of participants
|
28.2 Percentage of participants
|
19.8 Percentage of participants
|
13.2 Percentage of participants
|
12.1 Percentage of participants
|
0 Percentage of participants
|
61.5 Percentage of participants
|
|
Percentage of Participants With Clinical Response
Week 192
|
5.0 Percentage of participants
|
6.4 Percentage of participants
|
6.1 Percentage of participants
|
12.9 Percentage of participants
|
11.0 Percentage of participants
|
2.6 Percentage of participants
|
3.0 Percentage of participants
|
5.0 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants With Clinical Response
Week 240
|
3.9 Percentage of participants
|
4.6 Percentage of participants
|
1.5 Percentage of participants
|
3.5 Percentage of participants
|
2.2 Percentage of participants
|
2.6 Percentage of participants
|
0 Percentage of participants
|
5.0 Percentage of participants
|
38.5 Percentage of participants
|
Adverse Events
RPC01-3201/3202 Placebo
Serious events: 38 serious events
Other events: 104 other events
Deaths: 0 deaths
RPC01-3201/3202 Ozanimod 0.92 mg
Serious events: 59 serious events
Other events: 181 other events
Deaths: 0 deaths
RPC01-3203 Placebo-Placebo Completers
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
Serious events: 11 serious events
Other events: 44 other events
Deaths: 0 deaths
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
Serious events: 11 serious events
Other events: 38 other events
Deaths: 1 deaths
RPC01-3203 Placebo-Placebo Relapse
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
RPC01-2201 Ozanimod 0.92 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RPC01-3201/3202 Placebo
n=179 participants at risk
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 participants at risk
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 participants at risk
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Cardiac disorders
Bradycardia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Congenital, familial and genetic disorders
Urachal abnormality
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Eye disorders
Macular oedema
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Anal cyst
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Anal fistula
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Crohn's disease
|
12.3%
22/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.3%
24/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.5%
3/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
2/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Asthenia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Peripheral swelling
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Anal abscess
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Anal fistula infection
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Bronchitis
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
COVID-19
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Colonic abscess
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Leptospirosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pneumonia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Vascular disorders
Hypertension
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
Other adverse events
| Measure |
RPC01-3201/3202 Placebo
n=179 participants at risk
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3201/3202 Ozanimod 0.92 mg
n=329 participants at risk
Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Completers
n=66 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers
n=85 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers
n=91 participants at risk
Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Placebo-Placebo Relapse
n=38 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse
n=33 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse
n=20 participants at risk
Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
RPC01-2201 Ozanimod 0.92 mg
n=13 participants at risk
Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
7/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.2%
17/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.5%
3/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
9.4%
8/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.4%
4/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
5/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.4%
8/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.5%
5/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.3%
13/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
13.1%
43/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.5%
3/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
8.2%
7/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
11.0%
10/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Eye disorders
Visual impairment
|
2.2%
4/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
10/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.5%
18/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
4/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.7%
4/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.4%
2/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.8%
6/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
4/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.5%
3/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Crohn's disease
|
18.4%
33/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
10.9%
36/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.5%
3/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
8.2%
7/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.6%
6/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
21.1%
8/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Dental caries
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
9/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
11/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
2/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.9%
5/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Nausea
|
1.7%
3/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
10/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.5%
3/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.7%
3/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
4/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
11/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.4%
2/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Fatigue
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.8%
6/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Medical device pain
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Oedema peripheral
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.4%
2/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Peripheral swelling
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
General disorders
Pyrexia
|
6.1%
11/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
11/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.7%
4/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated steatohepatitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Bronchitis
|
3.4%
6/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
COVID-19
|
8.9%
16/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.6%
25/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.6%
5/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
10.6%
9/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
16.5%
15/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
23.1%
3/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Clostridium difficile colitis
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Herpes zoster
|
1.7%
3/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Lice infestation
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
8/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.2%
17/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.7%
4/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
3/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Pneumonia
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.4%
2/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Sinusitis
|
2.2%
4/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.7%
9/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.4%
2/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
9/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.5%
18/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
3/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Urinary tract infection
|
2.2%
4/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.7%
9/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Investigations
Blood fibrinogen increased
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
15/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
20/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.4%
2/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
5/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
2/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.4%
2/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Headache
|
8.9%
16/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
11/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
4.5%
3/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.5%
3/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Nervous system disorders
Paraesthesia
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Psychiatric disorders
Insomnia
|
1.1%
2/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
3/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
5/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.4%
2/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
3/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.61%
2/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
4/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
5/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
2/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.5%
1/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
15.4%
2/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.2%
2/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.30%
1/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.56%
1/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.91%
3/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
3/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
4/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
2/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.1%
1/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.7%
1/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
|
Vascular disorders
Hypertension
|
2.8%
5/179 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.3%
11/329 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
6.1%
4/66 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
1.2%
1/85 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/91 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
0.00%
0/13 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER