Trial Outcomes & Findings for A Study of PF-07258669 In Healthy Adult Participants (NCT NCT05113940)
NCT ID: NCT05113940
Last Updated: 2024-10-24
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)
Results posted on
2024-10-24
Participant Flow
This study consisted of two parts: Part A and Part B. A total of 120 participants were enrolled in the study.
Part A of this study was placebo-controlled evaluation of safety, tolerability, and PK of PF-07258669 after multiple ascending oral doses to healthy adult participants under 3 different dietary allocations: standard, high-carbohydrate high-calorie (HCHC), and high-fat, high-calorie (HFHC) diets. Part B was a 2-period, fixed-sequence, multiple-dose design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants.
Participant milestones
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Midazolam Then PF-07258669 + Midazolam: Standard Diet
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 milligram (mg) oral solution on Day 1 of Period 1 and then oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (18 Days)
STARTED
|
6
|
8
|
8
|
7
|
10
|
8
|
8
|
8
|
8
|
8
|
12
|
12
|
1
|
5
|
0
|
|
Part A (18 Days)
COMPLETED
|
6
|
8
|
7
|
6
|
9
|
8
|
8
|
8
|
8
|
8
|
12
|
10
|
1
|
5
|
0
|
|
Part A (18 Days)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part B- Period 1 (3 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part B- Period 1 (3 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part B- Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B- Period 2 (8 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part B- Period 2 (8 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Part B- Period 2 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Midazolam Then PF-07258669 + Midazolam: Standard Diet
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 milligram (mg) oral solution on Day 1 of Period 1 and then oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (18 Days)
Adverse Event
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part B- Period 2 (8 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of PF-07258669 In Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Midazolam Then PF-07258669 + Midazolam: Standard Diet
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 milligram (mg) oral solution on Day 1 of Period 1 and then oral PF-07258669 180 mg tablets, Q8H from Day 1 to Day 10 of Period 2. On Days 2 and 10 of Period 2, participants received midazolam 1 mg oral solution.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 Years
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
10 Participants
n=95 Participants
|
10 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
92 Participants
n=135 Participants
|
|
Age, Customized
45-64 Years
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
27 Participants
n=135 Participants
|
|
Age, Customized
Not disclosed
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
12 Participants
n=95 Participants
|
12 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
118 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Not disclosed
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
11 Participants
n=95 Participants
|
12 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
110 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=62 Participants
|
7 Participants
n=95 Participants
|
11 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
97 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
5 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (\<) 0.8\* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (\>) 1.2\* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (\>) 3.0\* ULN for alanine aminotransferase, \>1.3\* ULN for urea nitrogen, cholesterol, and triglycerides; \>1.030 for specific gravity (scalar), greater than or equal to (\>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
11 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (\>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) \>= 20 mmHg, standing systolic SBP (mmHg) less than (\<) 90 mmHg, \>= 160 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) \< 50 mmHg, \>= 90 mmHg, change \>= 20 mmHg increase, change \>= 20mmHg decrease; postural difference (supine standing) \>= 10 mmHg; standing \<50 mmHg, value \>=90 mmHg, change \>=20 mmHg increase, change \>=20 mmHg decrease, C) standing pulse rate (PR) greater than (\>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
SBP postural difference >=20mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing SBP Value < 90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing SBP Value >= 160 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing SBP Value >= 30 mmHg increase
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing SBP Value >= 30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP Value >= 30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP value < 50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP value >= 90 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP change >= 20 mmHg increase
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
DBP (mmHg) postural difference (supine standing)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing DBP value < 50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing DBP value >= 90 mmHg
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing DBP change >= 20 mmHg increase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing diastolic BP change >= 20 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing PR >140 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine SBP Change >= 30mmHg increase
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Supine DBP change >= 20 mmHg decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
ECG criteria: QTc corrected using Fridericia's formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (\<=) change \<= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: On Day -2 (2 days prior to dosing)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: On Day 7Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Day 14Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Day 21Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Day -1 (1 day prior to dosing)Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Day 7Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part A: Day 14Population: The safety analysis set for Part A included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part A.
All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 Participants
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Cmax was defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1
|
6.213 Nanogram per milliliter
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
Cmax is the maximum observed plasma concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
|
10.83 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Cmax was defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
|
11.73 Nanogram per milliliter
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1
|
18.56 Nanogram*hour per milliliter
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study.
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
|
30.27 Nanogram*hour per milliliter
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
|
40.41 Nanogram*hour per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1
|
19.35 Nanogram*hour per milliliter
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=10 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2
|
32.84 Nanogram*hour per milliliter
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and had at least one of the PK parameters of interest calculated, for Part B of the study. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2
|
41.16 Nanogram*hour per milliliter
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Cmax was defined as the maximum plasma concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14
Day 1
|
19.47 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
25.06 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
50.41 Nanogram per milliliter
Geometric Coefficient of Variation 22
|
45.99 Nanogram per milliliter
Geometric Coefficient of Variation 47
|
131.2 Nanogram per milliliter
Geometric Coefficient of Variation 32
|
468.3 Nanogram per milliliter
Geometric Coefficient of Variation 27
|
987.2 Nanogram per milliliter
Geometric Coefficient of Variation 28
|
1263 Nanogram per milliliter
Geometric Coefficient of Variation 37
|
1218 Nanogram per milliliter
Geometric Coefficient of Variation 42
|
1210 Nanogram per milliliter
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14
Day 14
|
21.96 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
27.91 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
59.76 Nanogram per milliliter
Geometric Coefficient of Variation 29
|
57.08 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
165.2 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
568.5 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
1246 Nanogram per milliliter
Geometric Coefficient of Variation 25
|
1464 Nanogram per milliliter
Geometric Coefficient of Variation 21
|
1772 Nanogram per milliliter
Geometric Coefficient of Variation 19
|
1750 Nanogram per milliliter
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Cmax was defined maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14
Day 1
|
9.742 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 25
|
8.352 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 22
|
8.403 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 22
|
7.666 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 47
|
6.562 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 32
|
7.803 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 27
|
7.899 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 28
|
7.013 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 37
|
6.770 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 42
|
6.719 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
|
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14
Day 14
|
10.99 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 22
|
9.301 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 25
|
9.952 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 29
|
9.515 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 39
|
8.269 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 25
|
9.473 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 26
|
9.982 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 25
|
8.134 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 22
|
9.849 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 19
|
9.723 Nanograms per milliliter per milligram
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Area under the plasma concentration-time profile from time zero to time tau, the dosing interval, where tau = 8 hours.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14
Day 1
|
46.27 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 26
|
60.42 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 27
|
113.6 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 15
|
107.2 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 42
|
388.1 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 38
|
1207 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 26
|
2597 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 29
|
3357 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 34
|
3361 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 27
|
3331 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
|
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14
Day 14
|
62.40 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 32
|
76.25 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 30
|
162.0 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 28
|
147.0 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 45
|
480.4 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 28
|
1795 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 26
|
3946 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 28
|
5313 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 31
|
5845 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 19
|
6074 Nanograms*hours per (/) milliliter
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14
Day 14
|
31.21 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 32
|
25.44 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 30
|
27.01 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 28
|
24.47 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 45
|
24.04 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 28
|
29.90 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 26
|
31.57 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 28
|
29.49 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 31
|
32.49 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 19
|
33.74 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
|
Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14
Day 1
|
23.16 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 26
|
20.15 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 27
|
18.93 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 15
|
17.87 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 42
|
19.42 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 38
|
20.14 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 26
|
20.75 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 29
|
18.64 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 34
|
18.67 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 27
|
18.52 Nanograms*hours/ milliliter/ milligrams
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
Tmax was defined as the time taken (in hours) to reach the maximum plasma drug concentration.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14
Day 1
|
1.000 Hours
Interval 0.5 to 1.5
|
1.000 Hours
Interval 0.5 to 1.05
|
0.5830 Hours
Interval 0.5 to 1.5
|
0.8265 Hours
Interval 0.5 to 1.13
|
1.010 Hours
Interval 0.5 to 2.0
|
1.000 Hours
Interval 0.5 to 1.5
|
1.000 Hours
Interval 0.5 to 1.5
|
1.000 Hours
Interval 1.0 to 1.05
|
1.000 Hours
Interval 0.55 to 1.5
|
0.5830 Hours
Interval 0.5 to 1.5
|
—
|
—
|
—
|
—
|
|
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14
Day 14
|
1.010 Hours
Interval 0.5 to 1.52
|
1.000 Hours
Interval 0.5 to 1.02
|
0.7415 Hours
Interval 0.5 to 1.5
|
0.7665 Hours
Interval 0.5 to 1.07
|
1.000 Hours
Interval 1.0 to 1.53
|
1.000 Hours
Interval 0.5 to 1.05
|
1.000 Hours
Interval 0.5 to 1.08
|
1.500 Hours
Interval 1.0 to 2.0
|
1.000 Hours
Interval 0.5 to 1.5
|
1.000 Hours
Interval 1.0 to 1.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Aetau was defined as the amount of unchanged drug recovered in urine during the dosing interval.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Amount of PF-0728669 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
|
0.004304 Milligrams
Geometric Coefficient of Variation 45
|
0.004490 Milligrams
Geometric Coefficient of Variation 153
|
0.01690 Milligrams
Geometric Coefficient of Variation 34
|
0.01462 Milligrams
Geometric Coefficient of Variation 49
|
0.04039 Milligrams
Geometric Coefficient of Variation 70
|
0.1440 Milligrams
Geometric Coefficient of Variation 43
|
0.3173 Milligrams
Geometric Coefficient of Variation 109
|
0.3371 Milligrams
Geometric Coefficient of Variation 188
|
0.3146 Milligrams
Geometric Coefficient of Variation 314
|
0.6581 Milligrams
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Aetau% was defined as the percentage of dose recovered in urine as unchanged drug.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Percentage Dose of PF-07258669 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
|
0.2152 Percentage of dose
Geometric Coefficient of Variation 45
|
0.1496 Percentage of dose
Geometric Coefficient of Variation 153
|
0.2814 Percentage of dose
Geometric Coefficient of Variation 34
|
0.2436 Percentage of dose
Geometric Coefficient of Variation 49
|
0.2020 Percentage of dose
Geometric Coefficient of Variation 70
|
0.2400 Percentage of dose
Geometric Coefficient of Variation 43
|
0.2536 Percentage of dose
Geometric Coefficient of Variation 109
|
0.1872 Percentage of dose
Geometric Coefficient of Variation 189
|
0.1748 Percentage of dose
Geometric Coefficient of Variation 314
|
0.3654 Percentage of dose
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14Population: PK analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of midazolam and/or study intervention and had at least one of the PK parameters of interest calculated, for part A of the study.
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=7 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=12 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=5 Participants
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Renal Clearance (CLr) of PF-07258669
|
0.06896 Liter/ hour
Geometric Coefficient of Variation 37
|
0.05887 Liter/ hour
Geometric Coefficient of Variation 171
|
0.1042 Liter/ hour
Geometric Coefficient of Variation 44
|
0.09946 Liter/ hour
Geometric Coefficient of Variation 33
|
0.08412 Liter/ hour
Geometric Coefficient of Variation 48
|
0.08026 Liter/ hour
Geometric Coefficient of Variation 55
|
0.08040 Liter/ hour
Geometric Coefficient of Variation 116
|
0.06341 Liter/ hour
Geometric Coefficient of Variation 241
|
0.05381 Liter/ hour
Geometric Coefficient of Variation 350
|
0.1083 Liter/ hour
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)Population: The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With TEAEs
|
2 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)Population: The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Vital signs examination included: supine systolic blood pressure with criteria change \>= 30 mmHg decrease, supine diastolic blood pressure with criteria value \>= 90 mmHg and change \>= 20 mmHg decrease.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing systolic blood pressure
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing diastolic blood pressure: value >= 90 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data
Standing diastolic blood pressure: value change >= 20 mmHg decrease
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)Population: The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Following ECG parameters were analyzed: QTCF interval with criteria 450 less than (\<) value less than or equal to (\<=) 480. A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QTc intervals and QRS complex. On Day 1 at -1 hour (h), -0.5h, and 0h prior to the morning dose, triplicate 12-lead ECGs were obtained approximately 2 to 4 minutes apart at each time point. The average of the triplicate ECG measurements over the 3 pre dose measurement times (total of 9 ECG measurements) collected before morning dose administration on Day 1 served as each participant's baseline QTc value.
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)Population: The safety analysis set for Part B included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention in Part B.
Laboratory parameters assessed included: hematology (monocytes, monocytes/leukocytes) with primary criteria greater than (\>) 1.2\*upper limit of normal (ULN), clinical chemistry (bilirubin, direct bilirubin and indirect bilirubin with primary criteria \>1.5\*ULN, alanine aminotransferase with primary criteria \>3.0\*ULN, creatine kinase with primary criteria \>2.0\*ULN, urobilinogen with primary criteria greater than or equal to (\>=)1, cholesterol and triglycerides-fasting with primary criteria \>1.3\*ULN), urinalysis (ketones and urine hemoglobin with primary criteria \>=1).
Outcome measures
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=11 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=9 Participants
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo: 18-60 Years (HC-HC Diet)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-07258669 6 mg: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-07258669 20 mg: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-07258669 60 mg: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-07258669 125 mg: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-07258669 180 mg: 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo: 18-60 Years (HF-HC Diet)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo: Japanese 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B Period 1: Midazolam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B Period 2: PF-07258669 + Midazolam (Day 2)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B Period 2: PF-07258669 + Midazolam (Day 10)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 participants at risk
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 participants at risk
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 participants at risk
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Part B Period 1: Midazolam
n=11 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
|
Part B Period 2: PF-07258669 + Midazolam (Day 2)
n=11 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
|
Part B Period 2: PF-07258669 + Midazolam (Day 10)
n=9 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
Other adverse events
| Measure |
Placebo: 18-60 Years (HC-HC Diet)
n=6 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on high carbohydrate-high calorie (HC-HC) diet, received placebo matched to PF-07258669 tablets orally, every eight hours (Q8H) for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 2 mg: 18-60 Years (HC-HC Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 2 milligrams (mg) tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 3 mg: 18-60 Years (HC-HC Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received oral PF-07258669 3 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (HC-HC Diet)
n=7 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HC-HC diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (Standard Diet)
n=10 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 6 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 6 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 20 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 20 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 60 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 60 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 125 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 125 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (Standard Diet)
n=8 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: 18-60 Years (HF-HC Diet)
n=12 participants at risk
Healthy participants aged 18-60 years who were on high fat-high calorie (HF-HC) diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: 18-60 Years (HF-HC Diet)
n=12 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on HF-HC diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Placebo: Japanese 18-60 Years (Standard Diet)
n=1 participants at risk
Healthy Japanese participants aged 18-60 years who were on standard diet, received placebo matched to PF-07258669 tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
PF-07258669 180 mg: Japanese 18-60 Years (Standard Diet)
n=5 participants at risk
Healthy Japanese participants aged 18-60 years who were on standard diet, received PF-07258669 180 mg tablets orally, Q8H for 14 consecutive days (only a single morning dose administered on Day 14).
|
Part B Period 1: Midazolam
n=11 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received midazolam 1 mg oral solution on Day 1 of Period 1.
|
Part B Period 2: PF-07258669 + Midazolam (Day 2)
n=11 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 2 of Period 2, participants received midazolam 1 mg oral solution.
|
Part B Period 2: PF-07258669 + Midazolam (Day 10)
n=9 participants at risk
Healthy non-Japanese participants aged 18-60 years who were on standard diet, received oral PF-07258669 180 mg tablets Q8H from Day 1 to 10 of Period 2. On day 10 of Period 2, participants received midazolam 1 mg oral solution.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Application site irritation
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
28.6%
2/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Energy increased
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Facial pain
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
37.5%
3/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Feeling cold
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Feeling hot
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Hunger
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
50.0%
4/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
18.2%
2/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Puncture site pain
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Thirst
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
General disorders
Vaccination site pain
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Eye disorders
Delayed light adaptation
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Eye disorders
Eye haemorrhage
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
1/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
37.5%
3/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
1/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
18.2%
2/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Investigations
SARS-CoV-2 test positive
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Metabolism and nutrition disorders
Increased appetite
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
1/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
2/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
33.3%
2/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
1/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
11.1%
1/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
1/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
37.5%
3/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
20.0%
2/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
50.0%
4/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
3/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
25.0%
2/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
14.3%
1/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Surgical and medical procedures
Arrhythmia prophylaxis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
12.5%
1/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
8.3%
1/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Vascular disorders
Vasoconstriction
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
10.0%
1/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Nervous system disorders
Drooling
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
9.1%
1/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/7 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/10 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/8 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/12 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/1 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/5 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
0.00%
0/11 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
11.1%
1/9 • Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days), Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention, for the given part of the study (Part A or B). Participants were analyzed according to the product they received.
|
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 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