Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity (NCT NCT04707313)
NCT ID: NCT04707313
Last Updated: 2024-11-05
Results Overview
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \[\*\](back-transformed LS Mean minus \[-\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
628 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2024-11-05
Participant Flow
A total of 1220 participants were screened (Cohorts 1 and 2: 926 and Cohort 3: 294), of which 592 failed screening and 628 were randomized (Cohorts 1 and 2: 499 and Cohort 3: 129) in the study. Data for participants with the same dose and dosing frequency from Cohorts 1 and 2 were combined as pre-specified in the statistical analysis plan.
Participant milestones
| Measure |
Cohorts 1 and 2: Placebo
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohort 3: Placebo
Participants received placebo matched to PF-06882961 BID, orally for 32 weeks.
|
Cohort 3: PF-06882961 80mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 140mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 200mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2(Week 1 - Week 26)
STARTED
|
71
|
62
|
64
|
64
|
38
|
63
|
37
|
64
|
36
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Received Treatment
|
71
|
62
|
63
|
64
|
38
|
63
|
37
|
63
|
36
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
COMPLETED
|
44
|
27
|
30
|
26
|
13
|
18
|
11
|
14
|
13
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
NOT COMPLETED
|
27
|
35
|
34
|
38
|
25
|
45
|
26
|
50
|
23
|
0
|
0
|
0
|
0
|
|
Cohort 3 (Week 0 to Week 32)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
37
|
37
|
36
|
|
Cohort 3 (Week 0 to Week 32)
Received Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
37
|
37
|
36
|
|
Cohort 3 (Week 0 to Week 32)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
13
|
15
|
11
|
|
Cohort 3 (Week 0 to Week 32)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
24
|
22
|
25
|
Reasons for withdrawal
| Measure |
Cohorts 1 and 2: Placebo
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohort 3: Placebo
Participants received placebo matched to PF-06882961 BID, orally for 32 weeks.
|
Cohort 3: PF-06882961 80mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 140mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 200mg BID (4-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2(Week 1 - Week 26)
Adverse Event
|
4
|
20
|
23
|
25
|
15
|
38
|
15
|
42
|
16
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Lack of Efficacy
|
5
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Lost to Follow-up
|
5
|
4
|
4
|
5
|
3
|
2
|
3
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Non-compliance with study drug
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Other
|
1
|
4
|
1
|
1
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Withdrawal by Subject
|
11
|
5
|
3
|
7
|
3
|
4
|
6
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Cohorts 1 and 2(Week 1 - Week 26)
Randomized not treated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3 (Week 0 to Week 32)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
16
|
18
|
|
Cohort 3 (Week 0 to Week 32)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
1
|
0
|
|
Cohort 3 (Week 0 to Week 32)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
5
|
2
|
3
|
|
Cohort 3 (Week 0 to Week 32)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Cohort 3 (Week 0 to Week 32)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Cohort 3 (Week 0 to Week 32)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
7
|
3
|
3
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Baseline characteristics by cohort
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohort 3: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 BID, orally for 32 weeks.
|
Cohort 3: PF-06882961 80mg BID (4-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 140mg BID (4-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 200mg BID (4-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks.
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
238 Participants
n=36 Participants
|
|
Age, Customized
45-64 years
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
329 Participants
n=36 Participants
|
|
Age, Customized
Greater than or equal to (>=)65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
59 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
397 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
229 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
51 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
34 Participants
n=36 Participants
|
569 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
67 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
76 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
28 Participants
n=36 Participants
|
473 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \[\*\](back-transformed LS Mean minus \[-\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
|
0.17 Percent change
Standard Error 0.008
|
-5.43 Percent change
Standard Error 0.009
|
-4.83 Percent change
Standard Error 0.009
|
-8.94 Percent change
Standard Error 0.009
|
-6.43 Percent change
Standard Error 0.012
|
-9.36 Percent change
Standard Error 0.010
|
-6.96 Percent change
Standard Error 0.013
|
-8.96 Percent change
Standard Error 0.011
|
-7.02 Percent change
Standard Error 0.012
|
PRIMARY outcome
Timeframe: Baseline, Week 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
|
1.40 Percent change
Standard Error 0.018
|
-6.92 Percent change
Standard Error 0.014
|
-7.15 Percent change
Standard Error 0.014
|
-11.65 Percent change
Standard Error 0.014
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus follow-up period).
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
TEAEs
|
50 Participants
|
52 Participants
|
59 Participants
|
54 Participants
|
32 Participants
|
59 Participants
|
30 Participants
|
59 Participants
|
30 Participants
|
|
Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
TESAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus lag time).
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants With TEAEs and TESAEs
TEAEs
|
13 Participants
|
30 Participants
|
34 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants With TEAEs and TESAEs
TESAEs
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=69 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=61 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=34 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=35 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
|
66 Participants
|
56 Participants
|
60 Participants
|
57 Participants
|
37 Participants
|
54 Participants
|
33 Participants
|
59 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=17 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=35 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=34 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
|
15 Participants
|
31 Participants
|
34 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \<50 mmHg, pulse rate (PR) \<40 beats per minute, \>120 beats per minute.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=70 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
SBP Value < 90
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
DBP Value < 50
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
PR <40 beats per minute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
PR >120 beats per minute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) \<90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) \<50 mmHg, pulse rate (PR) \<40 beats per minute, \>120 beats per minute.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=18 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
DBP Value < 50
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
SBP Value < 90
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
PR <40 beats per minute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
PR >120 beats per minute
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval \>=140; PR interval \>=300; QTCF interval \>500.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=69 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=61 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=34 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=35 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
QRS interval >=140
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
QTCF interval >500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
PR interval >=300
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval \>=140; PR interval \>=300; QTCF interval \>500.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=17 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=35 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=34 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants According to Categorization of ECG Parameters
QRS interval >=140
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants According to Categorization of ECG Parameters
QTCF interval >500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Number of Participants According to Categorization of ECG Parameters
PR interval >=300
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."
PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)Population: Safety analysis set included all participants randomly assigned to study intervention of the study and who took at least 1 dose of study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."
PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants with \>= 5% body weight loss at end of treatment were reported.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=44 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=27 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=30 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=26 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=14 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=18 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=11 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=14 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=13 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment
|
6 Participants
|
16 Participants
|
15 Participants
|
17 Participants
|
12 Participants
|
15 Participants
|
6 Participants
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants with \>= 5% body weight loss at end of treatment were reported.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=11 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=13 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=15 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=11 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment
|
0 Participants
|
9 Participants
|
11 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 22
|
-0.18 Percent Change
Standard Error 0.007
|
-5.06 Percent Change
Standard Error 0.008
|
-5.00 Percent Change
Standard Error 0.007
|
-8.10 Percent Change
Standard Error 0.008
|
-6.43 Percent Change
Standard Error 0.010
|
-8.63 Percent Change
Standard Error 0.009
|
-6.57 Percent Change
Standard Error 0.011
|
-8.23 Percent Change
Standard Error 0.009
|
-6.60 Percent Change
Standard Error 0.010
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 18
|
-0.50 Percent Change
Standard Error 0.006
|
-4.94 Percent Change
Standard Error 0.006
|
-4.68 Percent Change
Standard Error 0.006
|
-7.33 Percent Change
Standard Error 0.007
|
-6.33 Percent Change
Standard Error 0.008
|
-7.50 Percent Change
Standard Error 0.007
|
-5.57 Percent Change
Standard Error 0.009
|
-7.27 Percent Change
Standard Error 0.007
|
-5.80 Percent Change
Standard Error 0.008
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 16
|
-0.40 Percent Change
Standard Error 0.005
|
-4.73 Percent Change
Standard Error 0.006
|
-4.01 Percent Change
Standard Error 0.006
|
-6.98 Percent Change
Standard Error 0.006
|
-5.49 Percent Change
Standard Error 0.008
|
-7.04 Percent Change
Standard Error 0.007
|
-5.15 Percent Change
Standard Error 0.008
|
-6.56 Percent Change
Standard Error 0.007
|
-5.18 Percent Change
Standard Error 0.008
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 2
|
-0.13 Percent Change
Standard Error 0.001
|
-0.85 Percent Change
Standard Error 0.001
|
-0.54 Percent Change
Standard Error 0.001
|
-0.98 Percent Change
Standard Error 0.001
|
-0.58 Percent Change
Standard Error 0.002
|
-0.87 Percent Change
Standard Error 0.001
|
-0.22 Percent Change
Standard Error 0.002
|
-0.96 Percent Change
Standard Error 0.001
|
-0.53 Percent Change
Standard Error 0.002
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 4
|
-0.15 Percent Change
Standard Error 0.002
|
-1.65 Percent Change
Standard Error 0.002
|
-1.69 Percent Change
Standard Error 0.002
|
-1.99 Percent Change
Standard Error 0.002
|
-1.26 Percent Change
Standard Error 0.003
|
-1.71 Percent Change
Standard Error 0.002
|
-0.93 Percent Change
Standard Error 0.003
|
-1.98 Percent Change
Standard Error 0.002
|
-1.28 Percent Change
Standard Error 0.003
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 6
|
-0.24 Percent Change
Standard Error 0.003
|
-2.26 Percent Change
Standard Error 0.003
|
-2.37 Percent Change
Standard Error 0.003
|
-2.96 Percent Change
Standard Error 0.003
|
-1.99 Percent Change
Standard Error 0.003
|
-2.84 Percent Change
Standard Error 0.003
|
-1.93 Percent Change
Standard Error 0.004
|
-2.97 Percent Change
Standard Error 0.003
|
-1.99 Percent Change
Standard Error 0.004
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 8
|
-0.41 Percent Change
Standard Error 0.003
|
-2.93 Percent Change
Standard Error 0.003
|
-2.86 Percent Change
Standard Error 0.003
|
-3.89 Percent Change
Standard Error 0.003
|
-3.33 Percent Change
Standard Error 0.004
|
-3.87 Percent Change
Standard Error 0.004
|
-2.34 Percent Change
Standard Error 0.004
|
-3.83 Percent Change
Standard Error 0.004
|
-2.94 Percent Change
Standard Error 0.004
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 10
|
-0.50 Percent Change
Standard Error 0.004
|
-3.47 Percent Change
Standard Error 0.004
|
-3.33 Percent Change
Standard Error 0.004
|
-4.82 Percent Change
Standard Error 0.004
|
-3.92 Percent Change
Standard Error 0.005
|
-4.67 Percent Change
Standard Error 0.004
|
-3.20 Percent Change
Standard Error 0.005
|
-4.54 Percent Change
Standard Error 0.004
|
-3.83 Percent Change
Standard Error 0.005
|
|
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Week 12
|
-0.44 Percent Change
Standard Error 0.004
|
-3.89 Percent Change
Standard Error 0.005
|
-3.88 Percent Change
Standard Error 0.004
|
-5.31 Percent Change
Standard Error 0.005
|
-4.49 Percent Change
Standard Error 0.006
|
-5.66 Percent Change
Standard Error 0.005
|
-3.98 Percent Change
Standard Error 0.006
|
-5.33 Percent Change
Standard Error 0.005
|
-4.34 Percent Change
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 4
|
-0.37 Percent Change
Standard Error 0.004
|
-1.38 Percent Change
Standard Error 0.003
|
-0.95 Percent Change
Standard Error 0.003
|
-1.02 Percent Change
Standard Error 0.003
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 8
|
-0.06 Percent Change
Standard Error 0.006
|
-2.07 Percent Change
Standard Error 0.004
|
-1.93 Percent Change
Standard Error 0.004
|
-1.89 Percent Change
Standard Error 0.004
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 16
|
0.03 Percent Change
Standard Error 0.011
|
-4.13 Percent Change
Standard Error 0.008
|
-3.99 Percent Change
Standard Error 0.007
|
-4.73 Percent Change
Standard Error 0.008
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 12
|
-0.08 Percent Change
Standard Error 0.008
|
-2.80 Percent Change
Standard Error 0.006
|
-2.88 Percent Change
Standard Error 0.005
|
-2.96 Percent Change
Standard Error 0.006
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 24
|
0.36 Percent Change
Standard Error 0.015
|
-5.65 Percent Change
Standard Error 0.011
|
-6.39 Percent Change
Standard Error 0.011
|
-9.20 Percent Change
Standard Error 0.011
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 20
|
0.38 Percent Change
Standard Error 0.014
|
-5.17 Percent Change
Standard Error 0.010
|
-5.25 Percent Change
Standard Error 0.009
|
-7.10 Percent Change
Standard Error 0.010
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Week 28
|
1.06 Percent Change
Standard Error 0.017
|
-6.37 Percent Change
Standard Error 0.013
|
-6.74 Percent Change
Standard Error 0.012
|
-10.44 Percent Change
Standard Error 0.013
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26
|
-1.25 Centimeter
Standard Error 0.826
|
-6.49 Centimeter
Standard Error 0.995
|
-5.75 Centimeter
Standard Error 0.943
|
-6.19 Centimeter
Standard Error 1.023
|
-5.98 Centimeter
Standard Error 1.338
|
-9.05 Centimeter
Standard Error 1.174
|
-7.41 Centimeter
Standard Error 1.490
|
-7.56 Centimeter
Standard Error 1.281
|
-6.36 Centimeter
Standard Error 1.350
|
SECONDARY outcome
Timeframe: Baseline, Week 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32
|
0.19 Centimeter
Standard Error 1.967
|
-6.27 Centimeter
Standard Error 1.628
|
-7.77 Centimeter
Standard Error 1.564
|
-11.43 Centimeter
Standard Error 1.698
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Estimand Set 1 included all participants randomly assigned to study intervention in Part A and who took at least 1 dose of study intervention.
Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26
|
-0.002 Ratio
Standard Error 0.0064
|
-0.002 Ratio
Standard Error 0.0076
|
-0.015 Ratio
Standard Error 0.0073
|
0.001 Ratio
Standard Error 0.0078
|
-0.014 Ratio
Standard Error 0.0104
|
-0.015 Ratio
Standard Error 0.0090
|
-0.014 Ratio
Standard Error 0.0114
|
-0.007 Ratio
Standard Error 0.0098
|
0.004 Ratio
Standard Error 0.0104
|
SECONDARY outcome
Timeframe: Baseline, Week 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32
|
0.010 Ratio
Standard Error 0.0128
|
-0.012 Ratio
Standard Error 0.0113
|
-0.009 Ratio
Standard Error 0.0108
|
-0.016 Ratio
Standard Error 0.0121
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16 and 26Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26
Week 16
|
0.00 Percentage of HbA1c
Standard Error 0.034
|
-0.24 Percentage of HbA1c
Standard Error 0.039
|
-0.24 Percentage of HbA1c
Standard Error 0.039
|
-0.26 Percentage of HbA1c
Standard Error 0.042
|
-0.25 Percentage of HbA1c
Standard Error 0.056
|
-0.29 Percentage of HbA1c
Standard Error 0.050
|
-0.18 Percentage of HbA1c
Standard Error 0.061
|
-0.23 Percentage of HbA1c
Standard Error 0.053
|
-0.24 Percentage of HbA1c
Standard Error 0.054
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26
Week 26
|
0.01 Percentage of HbA1c
Standard Error 0.036
|
-0.17 Percentage of HbA1c
Standard Error 0.045
|
-0.13 Percentage of HbA1c
Standard Error 0.044
|
-0.22 Percentage of HbA1c
Standard Error 0.046
|
-0.16 Percentage of HbA1c
Standard Error 0.064
|
-0.31 Percentage of HbA1c
Standard Error 0.055
|
-0.13 Percentage of HbA1c
Standard Error 0.070
|
-0.17 Percentage of HbA1c
Standard Error 0.062
|
-0.26 Percentage of HbA1c
Standard Error 0.064
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 24 and 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
Week 24
|
0.05 Percentage of HbA1c
Standard Error 0.070
|
-0.13 Percentage of HbA1c
Standard Error 0.059
|
-0.21 Percentage of HbA1c
Standard Error 0.055
|
-0.31 Percentage of HbA1c
Standard Error 0.059
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
Week 32
|
-0.02 Percentage of HbA1c
Standard Error 0.074
|
-0.11 Percentage of HbA1c
Standard Error 0.064
|
-0.27 Percentage of HbA1c
Standard Error 0.059
|
-0.41 Percentage of HbA1c
Standard Error 0.068
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
Week 16
|
-0.05 Percentage of HbA1c
Standard Error 0.061
|
-0.16 Percentage of HbA1c
Standard Error 0.048
|
-0.26 Percentage of HbA1c
Standard Error 0.044
|
-0.29 Percentage of HbA1c
Standard Error 0.042
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=71 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=62 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 2
|
3.22 Milligram per deciliter
Standard Error 0.903
|
-2.93 Milligram per deciliter
Standard Error 0.963
|
-2.56 Milligram per deciliter
Standard Error 0.939
|
-4.02 Milligram per deciliter
Standard Error 0.940
|
-2.02 Milligram per deciliter
Standard Error 1.245
|
-4.51 Milligram per deciliter
Standard Error 0.957
|
-1.16 Milligram per deciliter
Standard Error 1.265
|
-2.82 Milligram per deciliter
Standard Error 0.939
|
-2.93 Milligram per deciliter
Standard Error 1.250
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 4
|
3.38 Milligram per deciliter
Standard Error 1.082
|
-2.75 Milligram per deciliter
Standard Error 1.196
|
-2.97 Milligram per deciliter
Standard Error 1.166
|
-3.59 Milligram per deciliter
Standard Error 1.155
|
-0.83 Milligram per deciliter
Standard Error 1.443
|
-4.81 Milligram per deciliter
Standard Error 1.199
|
-2.56 Milligram per deciliter
Standard Error 1.504
|
-6.24 Milligram per deciliter
Standard Error 1.164
|
-3.86 Milligram per deciliter
Standard Error 1.485
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 6
|
1.45 Milligram per deciliter
Standard Error 0.936
|
-4.28 Milligram per deciliter
Standard Error 1.021
|
-2.29 Milligram per deciliter
Standard Error 1.035
|
-6.38 Milligram per deciliter
Standard Error 1.044
|
-4.17 Milligram per deciliter
Standard Error 1.290
|
-3.46 Milligram per deciliter
Standard Error 1.102
|
-3.06 Milligram per deciliter
Standard Error 1.371
|
-4.32 Milligram per deciliter
Standard Error 1.095
|
-4.64 Milligram per deciliter
Standard Error 1.311
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 8
|
1.61 Milligram per deciliter
Standard Error 0.956
|
-3.72 Milligram per deciliter
Standard Error 1.068
|
-3.15 Milligram per deciliter
Standard Error 1.103
|
-2.56 Milligram per deciliter
Standard Error 1.130
|
-2.77 Milligram per deciliter
Standard Error 1.385
|
-4.48 Milligram per deciliter
Standard Error 1.177
|
-4.07 Milligram per deciliter
Standard Error 1.438
|
-4.90 Milligram per deciliter
Standard Error 1.248
|
-2.82 Milligram per deciliter
Standard Error 1.367
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 10
|
2.47 Milligram per deciliter
Standard Error 1.146
|
-2.52 Milligram per deciliter
Standard Error 1.264
|
-1.79 Milligram per deciliter
Standard Error 1.251
|
-4.74 Milligram per deciliter
Standard Error 1.353
|
-2.60 Milligram per deciliter
Standard Error 1.662
|
-4.17 Milligram per deciliter
Standard Error 1.498
|
-5.26 Milligram per deciliter
Standard Error 1.702
|
-5.35 Milligram per deciliter
Standard Error 1.525
|
-2.85 Milligram per deciliter
Standard Error 1.558
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 12
|
2.57 Milligram per deciliter
Standard Error 1.229
|
-2.70 Milligram per deciliter
Standard Error 1.408
|
-0.77 Milligram per deciliter
Standard Error 1.377
|
-2.24 Milligram per deciliter
Standard Error 1.492
|
-1.22 Milligram per deciliter
Standard Error 1.889
|
-4.86 Milligram per deciliter
Standard Error 1.686
|
-4.65 Milligram per deciliter
Standard Error 1.908
|
-3.01 Milligram per deciliter
Standard Error 1.716
|
-3.19 Milligram per deciliter
Standard Error 1.764
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 22
|
4.83 Milligram per deciliter
Standard Error 1.494
|
0.38 Milligram per deciliter
Standard Error 1.872
|
-3.22 Milligram per deciliter
Standard Error 1.712
|
-4.27 Milligram per deciliter
Standard Error 1.842
|
-1.78 Milligram per deciliter
Standard Error 2.502
|
-2.03 Milligram per deciliter
Standard Error 2.205
|
-1.65 Milligram per deciliter
Standard Error 2.888
|
-4.64 Milligram per deciliter
Standard Error 2.460
|
-5.08 Milligram per deciliter
Standard Error 2.580
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 16
|
0.50 Milligram per deciliter
Standard Error 1.352
|
-2.67 Milligram per deciliter
Standard Error 1.523
|
-2.04 Milligram per deciliter
Standard Error 1.537
|
-2.56 Milligram per deciliter
Standard Error 1.619
|
-6.99 Milligram per deciliter
Standard Error 2.143
|
-6.62 Milligram per deciliter
Standard Error 1.926
|
-5.73 Milligram per deciliter
Standard Error 2.338
|
-4.67 Milligram per deciliter
Standard Error 2.011
|
-5.24 Milligram per deciliter
Standard Error 2.097
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 18
|
4.34 Milligram per deciliter
Standard Error 1.407
|
-0.44 Milligram per deciliter
Standard Error 1.634
|
-3.73 Milligram per deciliter
Standard Error 1.593
|
0.19 Milligram per deciliter
Standard Error 1.770
|
-0.96 Milligram per deciliter
Standard Error 2.294
|
-4.76 Milligram per deciliter
Standard Error 2.030
|
-5.23 Milligram per deciliter
Standard Error 2.684
|
0.11 Milligram per deciliter
Standard Error 2.175
|
0.53 Milligram per deciliter
Standard Error 2.189
|
|
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Week 26
|
3.34 Milligram per deciliter
Standard Error 1.220
|
-3.37 Milligram per deciliter
Standard Error 1.499
|
-3.43 Milligram per deciliter
Standard Error 1.469
|
-4.02 Milligram per deciliter
Standard Error 1.555
|
-3.75 Milligram per deciliter
Standard Error 2.059
|
-6.00 Milligram per deciliter
Standard Error 1.804
|
-3.50 Milligram per deciliter
Standard Error 2.290
|
-6.60 Milligram per deciliter
Standard Error 2.010
|
-5.01 Milligram per deciliter
Standard Error 2.172
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32Population: Estimand Set 1 included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Outcome measures
| Measure |
Cohorts 1 and 2: Placebo
n=19 Participants
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=37 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=36 Participants
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 20
|
1.52 Milligram per deciliter
Standard Error 2.175
|
-1.95 Milligram per deciliter
Standard Error 1.774
|
-4.78 Milligram per deciliter
Standard Error 1.687
|
-1.39 Milligram per deciliter
Standard Error 1.628
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 28
|
1.67 Milligram per deciliter
Standard Error 2.518
|
-0.15 Milligram per deciliter
Standard Error 2.044
|
-4.53 Milligram per deciliter
Standard Error 1.983
|
0.90 Milligram per deciliter
Standard Error 2.221
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 32
|
-1.81 Milligram per deciliter
Standard Error 3.006
|
1.28 Milligram per deciliter
Standard Error 2.491
|
-1.65 Milligram per deciliter
Standard Error 2.446
|
-1.73 Milligram per deciliter
Standard Error 2.582
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 4
|
-1.82 Milligram per deciliter
Standard Error 2.327
|
-0.83 Milligram per deciliter
Standard Error 1.652
|
0.96 Milligram per deciliter
Standard Error 1.616
|
3.84 Milligram per deciliter
Standard Error 1.671
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 8
|
0.10 Milligram per deciliter
Standard Error 2.523
|
1.79 Milligram per deciliter
Standard Error 1.748
|
-1.16 Milligram per deciliter
Standard Error 1.659
|
2.52 Milligram per deciliter
Standard Error 1.720
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 12
|
-1.28 Milligram per deciliter
Standard Error 2.588
|
-1.80 Milligram per deciliter
Standard Error 1.883
|
1.56 Milligram per deciliter
Standard Error 1.755
|
-0.42 Milligram per deciliter
Standard Error 1.761
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 16
|
-5.75 Milligram per deciliter
Standard Error 2.348
|
-5.18 Milligram per deciliter
Standard Error 1.778
|
-2.43 Milligram per deciliter
Standard Error 1.654
|
0.88 Milligram per deciliter
Standard Error 1.618
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Week 24
|
-2.80 Milligram per deciliter
Standard Error 2.664
|
-0.13 Milligram per deciliter
Standard Error 2.088
|
-2.00 Milligram per deciliter
Standard Error 2.014
|
1.62 Milligram per deciliter
Standard Error 2.158
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohorts 1 and 2: Placebo
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort 1: PF-06882961 80mg BID (1-week Titration)
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Cohort 1: PF-06882961 120mg BID (1-week Titration)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3: PF-06882961 80mg BID (4-week Titration)
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Cohort 3: PF-06882961 140mg BID (4-week Titration)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 3: PF-06882961 200mg BID (4-week Titration)
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohorts 1 and 2: Placebo
n=71 participants at risk
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
n=62 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohort 3: Placebo
n=19 participants at risk
Participants received placebo matched to PF-06882961 BID, orally for 32 weeks.
|
Cohort 3: PF-06882961 80mg BID (4-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 140mg BID (4-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 200mg BID (4-week Titration)
n=36 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
COVID-19
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Cystitis
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
Other adverse events
| Measure |
Cohorts 1 and 2: Placebo
n=71 participants at risk
Participants received placebo matched to PF-06882961 twice daily (BID), orally for a total of 26 weeks.
|
Cohort 1: PF-06882961 40 mg BID (1-week Titration)
n=62 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 40 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 80mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 80 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 120mg BID (1-week Titration)
n=64 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)
n=38 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 120 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 160 mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 160 mg BID, for a total of 26 weeks.
|
Cohort 1: PF-06882961 200 mg BID (1-week Titration)
n=63 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 1-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)
n=36 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 2-week at each step to a target dose of 200 mg BID, for a total of 26 weeks.
|
Cohort 3: Placebo
n=19 participants at risk
Participants received placebo matched to PF-06882961 BID, orally for 32 weeks.
|
Cohort 3: PF-06882961 80mg BID (4-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 80 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 140mg BID (4-week Titration)
n=37 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 140 mg BID, for 32 weeks.
|
Cohort 3: PF-06882961 200mg BID (4-week Titration)
n=36 participants at risk
Participants received oral daily doses of PF-06882961, titrated with 4-week at each step to a target dose of 200 mg BID, for 32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.5%
4/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
5/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.7%
3/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.2%
5/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
4/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
5/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.1%
2/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
3/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.5%
6/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
2/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.4%
6/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
5/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
3/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
12.9%
8/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
15.9%
10/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.9%
7/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.2%
5/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
19.0%
12/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.8%
4/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
14.3%
9/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.7%
6/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
18.9%
7/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.9%
5/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
7/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
5/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
27.0%
17/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
18.8%
12/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
23.7%
9/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
20.6%
13/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
17.5%
11/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.7%
6/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
21.6%
8/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
21.6%
8/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
25.0%
9/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.7%
6/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
17.5%
11/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.8%
5/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.2%
5/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
20.6%
13/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
20.6%
13/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
11.1%
4/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.5%
5/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
19.4%
7/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.3%
4/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.5%
4/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
11.3%
7/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
12.7%
8/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
12.5%
8/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
26.3%
10/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.8%
4/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
15.9%
10/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.7%
6/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
22.2%
8/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
11/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
45.2%
28/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
61.9%
39/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
64.1%
41/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
57.9%
22/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
57.1%
36/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
67.6%
25/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
54.0%
34/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
50.0%
18/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
37.8%
14/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
73.0%
27/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
69.4%
25/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.1%
10/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
38.1%
24/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
40.6%
26/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
42.1%
16/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
42.9%
27/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
29.7%
11/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
46.0%
29/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
44.4%
16/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
37.8%
14/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
47.2%
17/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
General disorders
Chills
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
General disorders
Fatigue
|
7.0%
5/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.3%
4/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.9%
7/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.5%
6/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.5%
5/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
11.1%
7/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.5%
5/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
3/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.5%
4/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
12.7%
8/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.2%
4/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.3%
4/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.8%
4/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.9%
5/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Investigations
SARS-CoV-2 test positive
|
4.2%
3/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
2/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.5%
6/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.2%
4/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.3%
4/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
3/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
3.2%
2/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
5/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Dizziness
|
2.8%
2/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.5%
4/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.8%
5/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
2/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
6.3%
4/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.5%
6/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Headache
|
11.3%
8/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
9.7%
6/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
17.5%
11/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
17.2%
11/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
7.9%
3/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
17.5%
11/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.2%
6/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
11.1%
7/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
16.7%
6/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
15.8%
3/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
13.5%
5/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
11.1%
4/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Tremor
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
4.8%
3/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
4/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Vascular disorders
Hot flush
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.6%
1/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
1.6%
1/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
General disorders
Chest discomfort
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
COVID-19
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.3%
3/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Investigations
Lipase increased
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Investigations
Weight increased
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.6%
2/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
8.1%
3/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.4%
2/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Vascular disorders
Hypertension
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
10.5%
2/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.7%
1/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
2.8%
1/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Vascular disorders
Prehypertension
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/71 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/62 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/64 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/38 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/63 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
5.3%
1/19 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/37 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
0.00%
0/36 • From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to Week 31 for Cohort 1 and 2; maximum up to Week 37 for Cohort 3)
An AE was any untoward medical occurrence in a participant temporally associated with use of study intervention, whether or not considered related to study intervention. Same event may appear as both non-SAE and SAE; however, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. All-causality non-SAEs occurring in \>=5% of participants in any treatment group are included below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER